Plastic and Reconstructive Surgery Advance Online Article DOI: 10.1097/PRS.0000000000000026 Utility of Tongue Stitch and Nasal Trumpet in the
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Immediate Post-operative Outcome of Cleft Palatoplasty
Gallagher Sidhbh MD, Indiana University, Indianapolis Ferrera Alessandra, Indiana University, Indianapolis Spera Leigh MD, Indiana University, Indianapolis
EP
Eppley Barry L, MD DMD, Indiana University, Indianapolis Soleimani Tahereh, PhD, Indiana University, Indianapolis Tahiri Youssef MD, Indiana University, Indianapolis Sood Rajiv MD, Indiana University, Indianapolis
C
Flores Roberto L MD, New York University, New York
C
Wooden William A MD, Indiana University, Indianapolis Tholpady Sunil S MD Phd, Indiana University, Indianapolis
A
Acknowledgements:
Havlik, Robert MD, Medical College of Wisconsin, Wisconsin
From the Division of Plastic Surgery, Indiana University School of Medicine, Indianapolis, IN
1
Copyright © American Society of Plastic Surgeons. All rights reserved.
Corresponding Author: Sunil S. Tholpady, MD Division of Plastic Surgery
705 Riley Hospital Drive, RI 2511 Indianapolis, IN 46202 [email protected]
EP
317-274-2430
TE D
Riley Hospital for Children
Running Head: Tongue Stitch in Cleft Palate Repair
C
Author's role/participation in the authorship of the manuscript;
C
Gallagher Sidhbh MD, Data collection, statistical analysis and primary author Ferrera Alessandra, Data Collection
A
Spera Leigh MD, Data collection Eppley Barry L, MD DMD, Contributing surgeon, additional author and editing Soleimani Tahereh MD, Statistical Analysis Tahiri Youssef MD, Additional author and editing Sood Rajiv MD Contributing surgeon
2
Copyright © American Society of Plastic Surgeons. All rights reserved.
Flores Roberto MD, Contributing surgeon, additional author and editing Wooden William A MD, Contributing surgeon, additional author and editing
Acknowlegements
TE D
Tholpady Sunil S MD PhD, Statistical analysis, additional author and editing
Havlik, Robert MD , Contributing surgeon
None of the authors has a financial interest in any of the products, devices, or drugs
EP
mentioned in this manuscript.
The following work was completed with approval from Indiana University
A
C
C
Institutional Review Board.
3
Copyright © American Society of Plastic Surgeons. All rights reserved.
ABSTRACT
Background: Post-operative airway obstruction is a feared complication following cleft palate repair.. The aim of this study is to evaluate the effectiveness of tongue
TE D
stitches and nasal trumpets which have been used in an attempt to prevent this complication.
Methods: An eight-year (2005-2013) retrospective review of palatoplasties
EP
performed at a tertiary care center was performed. Patients were divided into three groups: those with no airway protective measure, those with a tongue stitch only, and a group with nasal trumpet and tongue stitch. Recorded variables included sex, age, Veau classification and co-morbidities. Primary outcomes measured were
C
C
post-operative respiratory distress, readmission and re-operative rates.
Results: 58 patients underwent palatoplasties with no airway protective measure,
A
252 patients only had tongue stitch, and 87 had tongue stitch and nasal trumpet. There were no significant differences between groups with respect to comorbidities except that Cleft lip was more prevalent in the no airway protection group than the other two groups (p =0.04). There was no significant difference in the incidence of re-intubation, ICU transfer, surgery related readmissions, or
4
Copyright © American Society of Plastic Surgeons. All rights reserved.
reoperations. Respiratory complications were significantly increased in the nasal trumpet group even after adjusting for age and weight. Length of stay was also significantly (p < 0.01) shortened when comparing no airway protection to those
TE D
who underwent both nasal trumpet and tongue suture placement.
Conclusions: The use of a tongue stitch, with or without nasal trumpet, did not correlate with improved safety and outcomes. Patients without these airway
A
C
C
EP
protective measures had a shorter hospital stay.
5
Copyright © American Society of Plastic Surgeons. All rights reserved.
INTRODUCTION
Repair of the clefted palate is the most common surgical procedure performed by plastic surgeons that affects the airway. Closure is necessary in the rehabilitation
TE D
of these patients for both feeding and speech functions. Palatal closure, however,
does have the effect of taking a large airway opening and converting it into a much smaller one. Post-surgical swelling can further reduce this airway diameter. Additionally, the use of a Dingman mouth gag can reduce tongue perfusion,
EP
leading to rebound tongue swelling after the procedure.1-3
All of these factors can lead to acute airway obstruction requiring ICU care, reintubation, or surgical airway in order to protect the child and airway. Because
C
loss of airway control can lead to death, much has been published on the potential
C
for airway complications after primary palatoplasty.1,4,5 These studies are mostly case reports or series that demonstrate the possibility of airway obstruction and
A
provide some inkling of which patients are more likely to suffer this complication.
Cleft palate surgery in the US is usually performed by practitioners who learn this technique in an apprenticeship manner. The two methods that have been routinely described and passed from teacher to student have been the tongue stitch and nasal
6
Copyright © American Society of Plastic Surgeons. All rights reserved.
trumpet.4,6 Ostensibly, the tongue stitch provides a mechanism for anterior displacement of the tongue out of the oropharynx in cases where this is contributing to the airway problem. The nasal trumpet completely bypasses the
TE D
repair and places a route for unobstructed breathing.
Although these safety methods are commonly used, there is currently very little evidence as to what precautions are necessary to prevent these airway
complications. Opinion is divided on whether tongue sutures are required7 and
EP
little is written about current practices of routine nasopharyngeal airway use in the post-operative phase. In an effort to determine the utility and necessity of tongue sutures and nasal trumpets in palatal surgery, an eight year retrospective review of cases with and without airway protective measures was performed.
C
C
METHODS
Indiana University institutional review board approval was obtained prior to the
A
start of the study. A retrospective analysis of all patients undergoing primary palate repair at Riley Hospital for Children between 2005 and 2013 was performed. Inclusion criteria for the study included children less than 24 months old at the time of surgery who had not undergone previous cleft repairs. Children were
7
Copyright © American Society of Plastic Surgeons. All rights reserved.
excluded if followup time was less than three months or if the medical record was incomplete.
Recorded variables included age at the time of surgery, sex, weight, surgeon,
TE D
length of follow up, use of a tongue suture or nasopharyngeal tube, and the
presence of co-morbidities including: syndromic, genetic, cardiac, gastrointestinal
(GI), respiratory, and central nervous system (CNS) anomalies. The presence of a cleft lip, Robin sequence, and Veau classification were also recorded. Outcome
EP
measures included length of surgery, ICU transfer, bleeding, respiratory
complications, readmissions related to surgery, re-intubations, death, re-operations within 3 months, and length of stay,. Respiratory complications were defined as any respiratory issue occurring on that admission including persistent desaturation,
C
stridor, and need for re-intubation. Readmissions were defined as admissions to
C
the hospital with any surgery related complication occurring within 30 days of the
A
surgery.
Patients were divided into three groups as determined by the use of adjunctive measures to protect the airway. The first group of patients was those without a nasal trumpet or tongue stitch. The second group had a tongue stitch only. The last group had both a tongue stitch and nasal trumpet. Postoperative outcomes
8
Copyright © American Society of Plastic Surgeons. All rights reserved.
were compared between the three groups. Fisher’s exact test was used for categorical variables and a Student’s t test was used for continuous variables using SPSS software (Version 20). A logistic regression model was created to determine if any independent variables were predictive of length of stay. Statistically
TE D
significant values were defined as p < 0.05. RESULTS
A total of 598 patients underwent primary palate repair during the study period. Of
EP
these patients, 397 patients met inclusion criteria and comprised the study
population. These 397 patients were then sub-divided in to no airway protective measure (n = 58), tongue stitch only (n = 252), and tongue stitch and nasal trumpet
C
repair.
C
groups (n = 87) based on the use of airway protective procedures after palate
In univariate analysis, patients in all groups had a similar sex distribution.
A
However, age at the time of surgery and operative weight was significantly different and greater in the no airway protection group (Table 1). Table 2 demonstrates Veau classifications in the three groups. There were fewer Veau I patients in the no airway protection group than the other two groups. Otherwise the groups had a similar distribution. The distribution of cardiac, GI, respiratory,
9
Copyright © American Society of Plastic Surgeons. All rights reserved.
genetic/syndromic, and other anomalies were similar between the three study groups (Table 3). Cleft lip was more prevalent in the no airway protection group (58.6%) than the other two groups (p = 0.04). There was a trend towards more genetic anomalies in the nasal trumpet group but this did not achieve significance
TE D
(p = 0.06).
There were no mortalities. There was no statistically significant difference in the incidence of re-intubation, ICU transfer, surgery related readmissions, or
EP
reoperations within 3 months of surgery (Table 4). Respiratory complications were significantly increased in the nasal trumpet group (p = 0.0003). These correlations remained significant after adjusting for age and weight.
C
Length of stay was also significantly (p < 0.01) shortened when comparing no
C
airway protection to those who underwent both nasal trumpet and tongue suture placement (Table 5). Subgroup analysis of patients with Robin Sequence and
A
congenital syndromes showed no statistically significant differences in the outcomes of either group (data not shown).
Logistic regression was performed to identify predictors of hospital stay longer than 1 day (Table 6). This analysis demonstrated that even after adjusting for age
10
Copyright © American Society of Plastic Surgeons. All rights reserved.
and weight, the patients who had tongue stitch as well as tongue stitch/nasal trumpet were 3.7 and 7.8 times more likely to stay longer than 1 day. It also revealed that age and weight were not significant predictors of length of stay. Thus the significant differences seen between the three groups regarding age and weight
TE D
did not translate into a significant difference in LOS.
DISCUSSION
EP
Palatoplasty is a common procedure performed by cleft surgeons. One of the most concerning complications associated with repair is peri-/post-operative respiratory compromise. Cleft palate repair narrows the velopharynx, requires dissection around bleeding prone structures, and is associated with swelling within the
C
airway. The incidence of perioperative airway complications after palatoplasty is between 4% and 38 %.5,8-10 This incidence increases in patients with a syndromic
A
C
diagnosis or Robin sequence.4,10,11
In order to prevent or to manage perioperative airway complications after cleft palate repair, many surgeons routinely use a tongue suture or nasopharyngeal tube to protect the airway. The effectiveness of these measures has not been demonstrated despite their widespread use. Furthermore, there could be potential
11
Copyright © American Society of Plastic Surgeons. All rights reserved.
added risk to the patient as these are additional procedures performed within and around the airway. Currently there is no consensus regarding the need for routine use of tongue sutures7 or nasopharyngeal airways in primary palate repairs, with surgeons being split on their utility. A literature search reveals a paucity of prior
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outcome studies evaluating the effectiveness of tongue sutures and nasopharyngeal tubes on perioperative airway outcomes after cleft palate repair.
This study presents an 8-year review of 397 consecutive palatoplasties in which
EP
three groups of similar palatoplasty patients are compared: those with and without the routine post-operative use of tongue sutures and protective nasopharyngeal airways. Subgroup analysis demonstrated no significant differences between groups except a higher rate of cleft lip in the no airway protection group and a
C
trend towards more Pierre Robin sequence in the nasal trumpet group. The results
C
demonstrate no significant differences in the rates of respiratory distress, reintubation, ICU transfer, surgery related readmissions, and re-operations within 3
A
months. Surgery times were significantly shorter in the group without a tongue suture. There were more respiratory complications in the nasal trumpet group. Because of the trend towards significance in the Pierre Robin sequence patients, additional analysis was performed by dropping out those patients and redoing the
12
Copyright © American Society of Plastic Surgeons. All rights reserved.
analysis. Although the significance decreased, all variables that were demonstrated to be significant remained so (data not shown).
Although this study was designed to determine the utility of airway protective
TE D
measures in preventing post-operative complications, an interesting result arose
from the LOS determination. The length of stay was shortened with lack of use of tongue stitch and markedly shortened without a nasal. Although demographically the patients with a shorter LOS were older and heavier, multivariate regression
EP
controlling for these factors demonstrated no contribution to the shortened LOS. While the result is interesting, the mechanism may be the addition of a tongue
suture and nasopharyngeal tube could contribute to poor feeding tolerance due to irritation to the tongue and nose. Poor feeding tolerance is a common reason for a
C
hospital stay greater than one day in this study population. No consistent
C
documentation of oral intake could be gleaned from hospital records, but this
A
hypothesis warrants further investigation.
Limitations of this study include the retrospective design and the potential for selection bias. A single surgeon comprised the entirety of the patient population without airway protective measures. Four other cleft surgeons participating in this study comprised the remaining patients. There is heterogeneity in surgical
13
Copyright © American Society of Plastic Surgeons. All rights reserved.
technique between the surgeons in the differing groups. The no airway protection surgeon uses primarily a Furlow palatoplasty, the operative time on average is 103 minutes. This could lead to less tongue base swelling and less airway compromise. Prolonged operative time is a known risk factor for airway complications with
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longer times leading to greater airway complications10. Although surgeon’s
preference and the increased patient weight could account for the decreased
hospital stay seen in those patients,9 multivariate logistic regression modelling
EP
determined that neither age nor weight correlated with length of stay.
The similarities between the groups with respect to perioperative airway complications like bleeding, reintubation, ICU admission, readmission, and reoperation within 3 months of surgery is encouraging. Respiratory complications
C
were increased in the nasal trumpet group. Because there were no pre-operative
C
demographic factors that could be linked to a higher odds ratio of respiratory complication, it is likely that some unmeasured factor is responsible for the
A
increase in respiratory complication. The factor could simply be the surgeon’s assessment of the child’s ability to have an uncomplicated course; even without preoperative demographics, a surgeon’s gestalt may be contributing to the coincidence of a nasal trumpet with respiratory complications. This experiential acumen may manifest itself either during or immediately after a case, and may be
14
Copyright © American Society of Plastic Surgeons. All rights reserved.
due to concerns that were expressed by any number of the operative staff including the surgeon and anesthesiologist. Retrospective analysis such as this cannot determine if such matters contributed to the use of an airway protective device; however, such bias has the real potential to exist in this study. Another hypothesis
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that is less likely is that the nasal trumpet is contributing to the respiratory failure.
This study suggests that the routine use of tongue sutures and nasopharyngeal tubes may provide no additional benefit to patients with cleft palate (with or
EP
without cleft lip) undergoing palatoplasty, and can be performed safely.
Additionally, it may increase LOS. Further investigation, ideally through a prospective and randomized design, would be required to extend the results of this study. One very important question that this study raises is whether the use of
C
routine protective airway maneuvers, like a tongue stitch or nasal trumpet, should
C
be ‘standard of practice’ in cleft palate surgery. By their historic and common use, many cleft surgeons may claim that they are. This study puts into question
A
their real value and further shows that no positive benefits were seen in a large patient population by their use.
In routine and non-syndromic cleft palate repair, the surgeon’s judgment of providing neither a tongue stitch nor a nasal trumpet at the conclusion of the
15
Copyright © American Society of Plastic Surgeons. All rights reserved.
surgery appears justified and does not compromise patient safety. In syndromic or high risk cleft palate patients, the use of a nasal trumpet and tongue stitch would
CONCLUSIONS
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seem to provide protection during the tenuous immediate post-operative period.
The use of a tongue stitch, with or without nasal trumpet, did not correlate with improved safety or outcomes. Interestingly, patients without these airway
EP
protective measures had a shorter hospital stay. Further study with prospective
A
C
C
trials is required to assess these differences.
16
Copyright © American Society of Plastic Surgeons. All rights reserved.
REFERENCES
1
Bell, C., Oh, T. H. & Loeffler, J. R. Massive macroglossia and airway obstruction after cleft palate repair. Anesthesia and analgesia 67, 71-74
2
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(1988).
Chan, M. T., Chan, M. S., Mui, K. S. & Ho, B. P. Massive lingual swelling following palatoplasty. An unusual cause of upper airway obstruction. Anaesthesia 50, 30-34 (1995).
Dell'Oste, C., Savron, F., Pelizzo, G. & Sarti, A. Acute airway obstruction in
EP
3
an infant with Pierre Robin syndrome after palatoplasty. Acta anaesthesiologica Scandinavica 48, 787-789, doi:10.1111/j.00015172.2004.00407.x (2004).
Antony, A. K. & Sloan, G. M. Airway obstruction following palatoplasty:
C
4
C
analysis of 247 consecutive operations. The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association
A
39, 145-148, doi:10.1597/1545-1569(2002)0392.0.CO;2 (2002).
5
Desalu, I., Adeyemo, W., Akintimoye, M. & Adepoju, A. Airway and
respiratory complications in children undergoing cleft lip and palate repair. Ghana medical journal 44, 16-20 (2010).
17
Copyright © American Society of Plastic Surgeons. All rights reserved.
6
Jackson, P., Whitaker, L. A. & Randall, P. Airway hazards associated with pharyngeal flaps in patients who have the Pierre Robin syndrome. Plastic and reconstructive surgery 58, 184-186 (1976).
7
Dorfman, D. W., Ciminello, F. S. & Wong, G. B. Tongue suture placement
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after cleft palate repair. The Journal of craniofacial surgery 21, 1601-1603, doi:10.1097/SCS.0b013e3181ebccb1 (2010). 8
Eriksson, M. & Henriksson, T. G. Risk factors in children having
palatoplasty. Scandinavian journal of plastic and reconstructive surgery and
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hand surgery / Nordisk plastikkirurgisk forening [and] Nordisk klubb for handkirurgi 35, 279-283 (2001). 9
Fillies, T. et al. Perioperative complications in infant cleft repair. Head & face medicine 3, 9, doi:10.1186/1746-160X-3-9 (2007). Jackson, O. et al. Perioperative risk factors for adverse airway events in
C
10
C
patients undergoing cleft palate repair. The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association
A
50, 330-336, doi:10.1597/12-134 (2013).
11
Lehman, J. A., Fishman, J. R. & Neiman, G. S. Treatment of cleft palate
associated with Robin sequence: appraisal of risk factors. The Cleft palatecraniofacial journal : official publication of the American Cleft Palate-
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Copyright © American Society of Plastic Surgeons. All rights reserved.
Craniofacial Association 32, 25-29, doi:10.1597/1545-
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C
C
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1569(1995)0322.3.CO;2 (1995).
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Copyright © American Society of Plastic Surgeons. All rights reserved.
TABLE LEGENDS
Table 1. Differences in patient demographics between the 3 groups.
protective measures.
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Table 2. Veau classification of palatal repairs subdivided by use of airway
EP
Table 3. Distribution of preoperative comorbidities between the 3 groups.
Table 4. Distribution of operative and postoperative characteristics between the 3 groups.
C
C
Table 5. Association of length of stay with airway support measures.
Table 6. Logistic regression results for dependent variable LOS >1 demonstrating
A
the significance of tongue stitch use and LOS but not age or weight.
20
Copyright © American Society of Plastic Surgeons. All rights reserved.
Table1. Demographics
Tongue Stitch N=252 M:127, F:125 436 9.6 kg
Nasal Trumpet N=87 M:51, F:36 466 9.8 kg
p value
0.37 < 0.0001 0.0002
A
C
C
EP
TE D
Gender Age (Mean) Weight (Mean)
No airway protection N=58 M:33, F:25 517 days 10.5 kg
21
Copyright © American Society of Plastic Surgeons. All rights reserved.
Table 2. Veau Classification I
No airway protection 5 (8.62%)
II
Nasal Trumpet
Total
54 (21.43%)
16 (18.39%)
76(19.0%)
22 (37.93%)
102 (40.48%)
39 (44.83%)
165(41.2%)
III
23 (39.66%)
77 (30.56%)
22 (25.29%)
122(30.5%)
IV
8 (13.79%)
18 (7.14%)
10 (11.49%)
36(9.0%)
A
C
C
EP
TE D
Tongue Stitch
22
Copyright © American Society of Plastic Surgeons. All rights reserved.
Table3. Tongue Stitch N=252
Nasal Trumpet N=87
p value
PierreRobin
8 (13.79%)
58 (23.02%)
26 (29.89%)
0.08
CNS Anomaly
6 (10.34%)
9 (3.73%)
3 (3.49%)
0.08
Cardiac Anomaly
3 (5.17%)
18 (7.47%)
10 (11.63%)
0.32
Cleft Lip
34 (58.62%)
105 (41.67%)
34 (39.08%)
0.04
GI Anomaly
5 (8.62%)
Genetic Anomaly
5 (8.62%)
Other Anomalies
7 (12.07%)
Respiratory Anomaly
3 (5.17%)
TE D
No airway protection N=58
16 (18.6%)
0.24
28 (11.97%)
17 (20.73%)
0.06
17 (7.05%)
7 (8.14%)
0.45
18 (7.47%)
12 (13.95%)
0.11
A
C
C
EP
34 (14.11%)
23
Copyright © American Society of Plastic Surgeons. All rights reserved.
Table4. Nasal Trumpet N=87 144.7 4 (4.65%) 0 (0%) 13 (14.94%) 2 (2.35%) 4 (4.65%) 3 (3.49%) 1 (1.16%)
p value 2 days
No airway protection
51 (87.93%)
6 (10.34%)
1 (1.72%)
Tongue Stitch
165 (67.62%)
53 (21.72%)
26 (10.66%)
Nasal Trumpet
41 (50%)
26 (31.71%)
15 (18.29%)
A
C
C
EP
TE D
≤ 1 day
25
Copyright © American Society of Plastic Surgeons. All rights reserved.
Table 6. CI
p value
No airway protection
Reference
-
-
Tongue Stitch
3.681
1.548 - 8.754
0.0001
Nasal Trumpet
7.845
3.12 - 19.726
TE D
Immediate Post-operative Outcome of Cleft Palatoplasty
Gallagher Sidhbh MD, Indiana University, Indianapolis Ferrera Alessandra, Indiana University, Indianapolis Spera Leigh MD, Indiana University, Indianapolis
EP
Eppley Barry L, MD DMD, Indiana University, Indianapolis Soleimani Tahereh, PhD, Indiana University, Indianapolis Tahiri Youssef MD, Indiana University, Indianapolis Sood Rajiv MD, Indiana University, Indianapolis
C
Flores Roberto L MD, New York University, New York
C
Wooden William A MD, Indiana University, Indianapolis Tholpady Sunil S MD Phd, Indiana University, Indianapolis
A
Acknowledgements:
Havlik, Robert MD, Medical College of Wisconsin, Wisconsin
From the Division of Plastic Surgery, Indiana University School of Medicine, Indianapolis, IN
1
Copyright © American Society of Plastic Surgeons. All rights reserved.
Corresponding Author: Sunil S. Tholpady, MD Division of Plastic Surgery
705 Riley Hospital Drive, RI 2511 Indianapolis, IN 46202 [email protected]
EP
317-274-2430
TE D
Riley Hospital for Children
Running Head: Tongue Stitch in Cleft Palate Repair
C
Author's role/participation in the authorship of the manuscript;
C
Gallagher Sidhbh MD, Data collection, statistical analysis and primary author Ferrera Alessandra, Data Collection
A
Spera Leigh MD, Data collection Eppley Barry L, MD DMD, Contributing surgeon, additional author and editing Soleimani Tahereh MD, Statistical Analysis Tahiri Youssef MD, Additional author and editing Sood Rajiv MD Contributing surgeon
2
Copyright © American Society of Plastic Surgeons. All rights reserved.
Flores Roberto MD, Contributing surgeon, additional author and editing Wooden William A MD, Contributing surgeon, additional author and editing
Acknowlegements
TE D
Tholpady Sunil S MD PhD, Statistical analysis, additional author and editing
Havlik, Robert MD , Contributing surgeon
None of the authors has a financial interest in any of the products, devices, or drugs
EP
mentioned in this manuscript.
The following work was completed with approval from Indiana University
A
C
C
Institutional Review Board.
3
Copyright © American Society of Plastic Surgeons. All rights reserved.
ABSTRACT
Background: Post-operative airway obstruction is a feared complication following cleft palate repair.. The aim of this study is to evaluate the effectiveness of tongue
TE D
stitches and nasal trumpets which have been used in an attempt to prevent this complication.
Methods: An eight-year (2005-2013) retrospective review of palatoplasties
EP
performed at a tertiary care center was performed. Patients were divided into three groups: those with no airway protective measure, those with a tongue stitch only, and a group with nasal trumpet and tongue stitch. Recorded variables included sex, age, Veau classification and co-morbidities. Primary outcomes measured were
C
C
post-operative respiratory distress, readmission and re-operative rates.
Results: 58 patients underwent palatoplasties with no airway protective measure,
A
252 patients only had tongue stitch, and 87 had tongue stitch and nasal trumpet. There were no significant differences between groups with respect to comorbidities except that Cleft lip was more prevalent in the no airway protection group than the other two groups (p =0.04). There was no significant difference in the incidence of re-intubation, ICU transfer, surgery related readmissions, or
4
Copyright © American Society of Plastic Surgeons. All rights reserved.
reoperations. Respiratory complications were significantly increased in the nasal trumpet group even after adjusting for age and weight. Length of stay was also significantly (p < 0.01) shortened when comparing no airway protection to those
TE D
who underwent both nasal trumpet and tongue suture placement.
Conclusions: The use of a tongue stitch, with or without nasal trumpet, did not correlate with improved safety and outcomes. Patients without these airway
A
C
C
EP
protective measures had a shorter hospital stay.
5
Copyright © American Society of Plastic Surgeons. All rights reserved.
INTRODUCTION
Repair of the clefted palate is the most common surgical procedure performed by plastic surgeons that affects the airway. Closure is necessary in the rehabilitation
TE D
of these patients for both feeding and speech functions. Palatal closure, however,
does have the effect of taking a large airway opening and converting it into a much smaller one. Post-surgical swelling can further reduce this airway diameter. Additionally, the use of a Dingman mouth gag can reduce tongue perfusion,
EP
leading to rebound tongue swelling after the procedure.1-3
All of these factors can lead to acute airway obstruction requiring ICU care, reintubation, or surgical airway in order to protect the child and airway. Because
C
loss of airway control can lead to death, much has been published on the potential
C
for airway complications after primary palatoplasty.1,4,5 These studies are mostly case reports or series that demonstrate the possibility of airway obstruction and
A
provide some inkling of which patients are more likely to suffer this complication.
Cleft palate surgery in the US is usually performed by practitioners who learn this technique in an apprenticeship manner. The two methods that have been routinely described and passed from teacher to student have been the tongue stitch and nasal
6
Copyright © American Society of Plastic Surgeons. All rights reserved.
trumpet.4,6 Ostensibly, the tongue stitch provides a mechanism for anterior displacement of the tongue out of the oropharynx in cases where this is contributing to the airway problem. The nasal trumpet completely bypasses the
TE D
repair and places a route for unobstructed breathing.
Although these safety methods are commonly used, there is currently very little evidence as to what precautions are necessary to prevent these airway
complications. Opinion is divided on whether tongue sutures are required7 and
EP
little is written about current practices of routine nasopharyngeal airway use in the post-operative phase. In an effort to determine the utility and necessity of tongue sutures and nasal trumpets in palatal surgery, an eight year retrospective review of cases with and without airway protective measures was performed.
C
C
METHODS
Indiana University institutional review board approval was obtained prior to the
A
start of the study. A retrospective analysis of all patients undergoing primary palate repair at Riley Hospital for Children between 2005 and 2013 was performed. Inclusion criteria for the study included children less than 24 months old at the time of surgery who had not undergone previous cleft repairs. Children were
7
Copyright © American Society of Plastic Surgeons. All rights reserved.
excluded if followup time was less than three months or if the medical record was incomplete.
Recorded variables included age at the time of surgery, sex, weight, surgeon,
TE D
length of follow up, use of a tongue suture or nasopharyngeal tube, and the
presence of co-morbidities including: syndromic, genetic, cardiac, gastrointestinal
(GI), respiratory, and central nervous system (CNS) anomalies. The presence of a cleft lip, Robin sequence, and Veau classification were also recorded. Outcome
EP
measures included length of surgery, ICU transfer, bleeding, respiratory
complications, readmissions related to surgery, re-intubations, death, re-operations within 3 months, and length of stay,. Respiratory complications were defined as any respiratory issue occurring on that admission including persistent desaturation,
C
stridor, and need for re-intubation. Readmissions were defined as admissions to
C
the hospital with any surgery related complication occurring within 30 days of the
A
surgery.
Patients were divided into three groups as determined by the use of adjunctive measures to protect the airway. The first group of patients was those without a nasal trumpet or tongue stitch. The second group had a tongue stitch only. The last group had both a tongue stitch and nasal trumpet. Postoperative outcomes
8
Copyright © American Society of Plastic Surgeons. All rights reserved.
were compared between the three groups. Fisher’s exact test was used for categorical variables and a Student’s t test was used for continuous variables using SPSS software (Version 20). A logistic regression model was created to determine if any independent variables were predictive of length of stay. Statistically
TE D
significant values were defined as p < 0.05. RESULTS
A total of 598 patients underwent primary palate repair during the study period. Of
EP
these patients, 397 patients met inclusion criteria and comprised the study
population. These 397 patients were then sub-divided in to no airway protective measure (n = 58), tongue stitch only (n = 252), and tongue stitch and nasal trumpet
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repair.
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groups (n = 87) based on the use of airway protective procedures after palate
In univariate analysis, patients in all groups had a similar sex distribution.
A
However, age at the time of surgery and operative weight was significantly different and greater in the no airway protection group (Table 1). Table 2 demonstrates Veau classifications in the three groups. There were fewer Veau I patients in the no airway protection group than the other two groups. Otherwise the groups had a similar distribution. The distribution of cardiac, GI, respiratory,
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genetic/syndromic, and other anomalies were similar between the three study groups (Table 3). Cleft lip was more prevalent in the no airway protection group (58.6%) than the other two groups (p = 0.04). There was a trend towards more genetic anomalies in the nasal trumpet group but this did not achieve significance
TE D
(p = 0.06).
There were no mortalities. There was no statistically significant difference in the incidence of re-intubation, ICU transfer, surgery related readmissions, or
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reoperations within 3 months of surgery (Table 4). Respiratory complications were significantly increased in the nasal trumpet group (p = 0.0003). These correlations remained significant after adjusting for age and weight.
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Length of stay was also significantly (p < 0.01) shortened when comparing no
C
airway protection to those who underwent both nasal trumpet and tongue suture placement (Table 5). Subgroup analysis of patients with Robin Sequence and
A
congenital syndromes showed no statistically significant differences in the outcomes of either group (data not shown).
Logistic regression was performed to identify predictors of hospital stay longer than 1 day (Table 6). This analysis demonstrated that even after adjusting for age
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and weight, the patients who had tongue stitch as well as tongue stitch/nasal trumpet were 3.7 and 7.8 times more likely to stay longer than 1 day. It also revealed that age and weight were not significant predictors of length of stay. Thus the significant differences seen between the three groups regarding age and weight
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did not translate into a significant difference in LOS.
DISCUSSION
EP
Palatoplasty is a common procedure performed by cleft surgeons. One of the most concerning complications associated with repair is peri-/post-operative respiratory compromise. Cleft palate repair narrows the velopharynx, requires dissection around bleeding prone structures, and is associated with swelling within the
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airway. The incidence of perioperative airway complications after palatoplasty is between 4% and 38 %.5,8-10 This incidence increases in patients with a syndromic
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C
diagnosis or Robin sequence.4,10,11
In order to prevent or to manage perioperative airway complications after cleft palate repair, many surgeons routinely use a tongue suture or nasopharyngeal tube to protect the airway. The effectiveness of these measures has not been demonstrated despite their widespread use. Furthermore, there could be potential
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added risk to the patient as these are additional procedures performed within and around the airway. Currently there is no consensus regarding the need for routine use of tongue sutures7 or nasopharyngeal airways in primary palate repairs, with surgeons being split on their utility. A literature search reveals a paucity of prior
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outcome studies evaluating the effectiveness of tongue sutures and nasopharyngeal tubes on perioperative airway outcomes after cleft palate repair.
This study presents an 8-year review of 397 consecutive palatoplasties in which
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three groups of similar palatoplasty patients are compared: those with and without the routine post-operative use of tongue sutures and protective nasopharyngeal airways. Subgroup analysis demonstrated no significant differences between groups except a higher rate of cleft lip in the no airway protection group and a
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trend towards more Pierre Robin sequence in the nasal trumpet group. The results
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demonstrate no significant differences in the rates of respiratory distress, reintubation, ICU transfer, surgery related readmissions, and re-operations within 3
A
months. Surgery times were significantly shorter in the group without a tongue suture. There were more respiratory complications in the nasal trumpet group. Because of the trend towards significance in the Pierre Robin sequence patients, additional analysis was performed by dropping out those patients and redoing the
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Copyright © American Society of Plastic Surgeons. All rights reserved.
analysis. Although the significance decreased, all variables that were demonstrated to be significant remained so (data not shown).
Although this study was designed to determine the utility of airway protective
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measures in preventing post-operative complications, an interesting result arose
from the LOS determination. The length of stay was shortened with lack of use of tongue stitch and markedly shortened without a nasal. Although demographically the patients with a shorter LOS were older and heavier, multivariate regression
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controlling for these factors demonstrated no contribution to the shortened LOS. While the result is interesting, the mechanism may be the addition of a tongue
suture and nasopharyngeal tube could contribute to poor feeding tolerance due to irritation to the tongue and nose. Poor feeding tolerance is a common reason for a
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hospital stay greater than one day in this study population. No consistent
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documentation of oral intake could be gleaned from hospital records, but this
A
hypothesis warrants further investigation.
Limitations of this study include the retrospective design and the potential for selection bias. A single surgeon comprised the entirety of the patient population without airway protective measures. Four other cleft surgeons participating in this study comprised the remaining patients. There is heterogeneity in surgical
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technique between the surgeons in the differing groups. The no airway protection surgeon uses primarily a Furlow palatoplasty, the operative time on average is 103 minutes. This could lead to less tongue base swelling and less airway compromise. Prolonged operative time is a known risk factor for airway complications with
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longer times leading to greater airway complications10. Although surgeon’s
preference and the increased patient weight could account for the decreased
hospital stay seen in those patients,9 multivariate logistic regression modelling
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determined that neither age nor weight correlated with length of stay.
The similarities between the groups with respect to perioperative airway complications like bleeding, reintubation, ICU admission, readmission, and reoperation within 3 months of surgery is encouraging. Respiratory complications
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were increased in the nasal trumpet group. Because there were no pre-operative
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demographic factors that could be linked to a higher odds ratio of respiratory complication, it is likely that some unmeasured factor is responsible for the
A
increase in respiratory complication. The factor could simply be the surgeon’s assessment of the child’s ability to have an uncomplicated course; even without preoperative demographics, a surgeon’s gestalt may be contributing to the coincidence of a nasal trumpet with respiratory complications. This experiential acumen may manifest itself either during or immediately after a case, and may be
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due to concerns that were expressed by any number of the operative staff including the surgeon and anesthesiologist. Retrospective analysis such as this cannot determine if such matters contributed to the use of an airway protective device; however, such bias has the real potential to exist in this study. Another hypothesis
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that is less likely is that the nasal trumpet is contributing to the respiratory failure.
This study suggests that the routine use of tongue sutures and nasopharyngeal tubes may provide no additional benefit to patients with cleft palate (with or
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without cleft lip) undergoing palatoplasty, and can be performed safely.
Additionally, it may increase LOS. Further investigation, ideally through a prospective and randomized design, would be required to extend the results of this study. One very important question that this study raises is whether the use of
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routine protective airway maneuvers, like a tongue stitch or nasal trumpet, should
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be ‘standard of practice’ in cleft palate surgery. By their historic and common use, many cleft surgeons may claim that they are. This study puts into question
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their real value and further shows that no positive benefits were seen in a large patient population by their use.
In routine and non-syndromic cleft palate repair, the surgeon’s judgment of providing neither a tongue stitch nor a nasal trumpet at the conclusion of the
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surgery appears justified and does not compromise patient safety. In syndromic or high risk cleft palate patients, the use of a nasal trumpet and tongue stitch would
CONCLUSIONS
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seem to provide protection during the tenuous immediate post-operative period.
The use of a tongue stitch, with or without nasal trumpet, did not correlate with improved safety or outcomes. Interestingly, patients without these airway
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protective measures had a shorter hospital stay. Further study with prospective
A
C
C
trials is required to assess these differences.
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REFERENCES
1
Bell, C., Oh, T. H. & Loeffler, J. R. Massive macroglossia and airway obstruction after cleft palate repair. Anesthesia and analgesia 67, 71-74
2
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(1988).
Chan, M. T., Chan, M. S., Mui, K. S. & Ho, B. P. Massive lingual swelling following palatoplasty. An unusual cause of upper airway obstruction. Anaesthesia 50, 30-34 (1995).
Dell'Oste, C., Savron, F., Pelizzo, G. & Sarti, A. Acute airway obstruction in
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3
an infant with Pierre Robin syndrome after palatoplasty. Acta anaesthesiologica Scandinavica 48, 787-789, doi:10.1111/j.00015172.2004.00407.x (2004).
Antony, A. K. & Sloan, G. M. Airway obstruction following palatoplasty:
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4
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analysis of 247 consecutive operations. The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association
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39, 145-148, doi:10.1597/1545-1569(2002)0392.0.CO;2 (2002).
5
Desalu, I., Adeyemo, W., Akintimoye, M. & Adepoju, A. Airway and
respiratory complications in children undergoing cleft lip and palate repair. Ghana medical journal 44, 16-20 (2010).
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Copyright © American Society of Plastic Surgeons. All rights reserved.
6
Jackson, P., Whitaker, L. A. & Randall, P. Airway hazards associated with pharyngeal flaps in patients who have the Pierre Robin syndrome. Plastic and reconstructive surgery 58, 184-186 (1976).
7
Dorfman, D. W., Ciminello, F. S. & Wong, G. B. Tongue suture placement
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after cleft palate repair. The Journal of craniofacial surgery 21, 1601-1603, doi:10.1097/SCS.0b013e3181ebccb1 (2010). 8
Eriksson, M. & Henriksson, T. G. Risk factors in children having
palatoplasty. Scandinavian journal of plastic and reconstructive surgery and
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hand surgery / Nordisk plastikkirurgisk forening [and] Nordisk klubb for handkirurgi 35, 279-283 (2001). 9
Fillies, T. et al. Perioperative complications in infant cleft repair. Head & face medicine 3, 9, doi:10.1186/1746-160X-3-9 (2007). Jackson, O. et al. Perioperative risk factors for adverse airway events in
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10
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patients undergoing cleft palate repair. The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association
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50, 330-336, doi:10.1597/12-134 (2013).
11
Lehman, J. A., Fishman, J. R. & Neiman, G. S. Treatment of cleft palate
associated with Robin sequence: appraisal of risk factors. The Cleft palatecraniofacial journal : official publication of the American Cleft Palate-
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Copyright © American Society of Plastic Surgeons. All rights reserved.
Craniofacial Association 32, 25-29, doi:10.1597/1545-
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C
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1569(1995)0322.3.CO;2 (1995).
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TABLE LEGENDS
Table 1. Differences in patient demographics between the 3 groups.
protective measures.
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Table 2. Veau classification of palatal repairs subdivided by use of airway
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Table 3. Distribution of preoperative comorbidities between the 3 groups.
Table 4. Distribution of operative and postoperative characteristics between the 3 groups.
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Table 5. Association of length of stay with airway support measures.
Table 6. Logistic regression results for dependent variable LOS >1 demonstrating
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the significance of tongue stitch use and LOS but not age or weight.
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Table1. Demographics
Tongue Stitch N=252 M:127, F:125 436 9.6 kg
Nasal Trumpet N=87 M:51, F:36 466 9.8 kg
p value
0.37 < 0.0001 0.0002
A
C
C
EP
TE D
Gender Age (Mean) Weight (Mean)
No airway protection N=58 M:33, F:25 517 days 10.5 kg
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Table 2. Veau Classification I
No airway protection 5 (8.62%)
II
Nasal Trumpet
Total
54 (21.43%)
16 (18.39%)
76(19.0%)
22 (37.93%)
102 (40.48%)
39 (44.83%)
165(41.2%)
III
23 (39.66%)
77 (30.56%)
22 (25.29%)
122(30.5%)
IV
8 (13.79%)
18 (7.14%)
10 (11.49%)
36(9.0%)
A
C
C
EP
TE D
Tongue Stitch
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Table3. Tongue Stitch N=252
Nasal Trumpet N=87
p value
PierreRobin
8 (13.79%)
58 (23.02%)
26 (29.89%)
0.08
CNS Anomaly
6 (10.34%)
9 (3.73%)
3 (3.49%)
0.08
Cardiac Anomaly
3 (5.17%)
18 (7.47%)
10 (11.63%)
0.32
Cleft Lip
34 (58.62%)
105 (41.67%)
34 (39.08%)
0.04
GI Anomaly
5 (8.62%)
Genetic Anomaly
5 (8.62%)
Other Anomalies
7 (12.07%)
Respiratory Anomaly
3 (5.17%)
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No airway protection N=58
16 (18.6%)
0.24
28 (11.97%)
17 (20.73%)
0.06
17 (7.05%)
7 (8.14%)
0.45
18 (7.47%)
12 (13.95%)
0.11
A
C
C
EP
34 (14.11%)
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Table4. Nasal Trumpet N=87 144.7 4 (4.65%) 0 (0%) 13 (14.94%) 2 (2.35%) 4 (4.65%) 3 (3.49%) 1 (1.16%)
p value 2 days
No airway protection
51 (87.93%)
6 (10.34%)
1 (1.72%)
Tongue Stitch
165 (67.62%)
53 (21.72%)
26 (10.66%)
Nasal Trumpet
41 (50%)
26 (31.71%)
15 (18.29%)
A
C
C
EP
TE D
≤ 1 day
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Table 6. CI
p value
No airway protection
Reference
-
-
Tongue Stitch
3.681
1.548 - 8.754
0.0001
Nasal Trumpet
7.845
3.12 - 19.726
