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Effect of CPAP and Adenotonsillectomy in Upper Airway Volume of Children With OSAS

Primary Purpose

Sleep Apnea, Obstructive, Child, Continuous Positive Airway Pressure

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Continuous positive airway pressure (CPAP)
Sponsored by
Instituto Nacional de Enfermedades Respiratorias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Apnea, Obstructive focused on measuring Sleep Apnea, Obstructive, Child, Continuous Positive Airway Pressure, Perioperative management, Adenotonsillectomy, Acoustic pharyngometry

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 4 and 14 years old. Both genders. Diagnosis of OSAS based on sleep study (respiratory polygraphy or polysomnography).

Surgical treatment planned by the ORL department of the Institute of Respiratory Diseases of Mexico.

Residents of the Metropolitan Area of Mexico City Parents and child accept to particpate in the study, singning informed consent and assent.

Exclusion Criteria:

  • Previous surgery in upper airway. Craneofacial malformation. Previous use of CPAP. Syndromatic patient.

Sites / Locations

  • Instituto Nacional Enfermedades RespiratoriasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Therapeutic

Suboptimal

Severe OSAS

Arm Description

Continuous positive airway pressure (CPAP) with automatic pressure from 4 to 15 cmH2O every night for one week, afterwards use of CPAP at the P90 of pressure determinated during automatic use for one week, via oronasal interface.

Continuous positive airway pressure (CPAP) every night for two weeks at fixed pressure of 4 cmH2O, via oronasal interface.

Continuous positive airway pressure (CPAP) with automatic pressure from 4 to 15 cmH2O every night for one week, afterwards use of CPAP at the P90 of pressure determinated during automatic use for one week, via oronasal interface.

Outcomes

Primary Outcome Measures

Oropharyngeal volume postCPAP.
Upper airway volume as measured by acoustic pharyngometry.

Secondary Outcome Measures

Oropharyngeal volume post-surgery
Upper airway volume as measured by acoustic pharyngometry.
OSA-18.
Score in que quality of life questionnaire OSA-18.
OSA-18.
Score in que quality of life questionnaire OSA-18.
Pediatric Sleep Questionnaire.
Symptoms as described in the pediatric sleep questionnaire.
Pediatric Sleep Questionnaire.
Symptoms as described in the pediatric sleep questionnaire.
Surgical complications.
Complications during or after the surgical procedure, as determined by checklist.

Full Information

First Posted
May 25, 2017
Last Updated
March 9, 2019
Sponsor
Instituto Nacional de Enfermedades Respiratorias
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1. Study Identification

Unique Protocol Identification Number
NCT03169491
Brief Title
Effect of CPAP and Adenotonsillectomy in Upper Airway Volume of Children With OSAS
Official Title
Caliber of Upper Airway Measured by Acoustic Pharyngometry in Children With Obstructive Sleep Apnea Before and After the Use of Presurgical CPAP and After Adentonsillectomy, and Their Relation With Surgical Complications and Residual Apneas
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 4, 2016 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Enfermedades Respiratorias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Obstructive sleep apnea syndrome (OSAS) in children has high prevalence and severe complications, and its first line of treatment (adenotonsillectomy) has risk of complications. Even though the use of presurgical CPAP seems logical due to its effects in adults, it must be studied in children due to the different physiopathology and adherence. One non-invasive way of study the effect is via acoustic pharyngometry, which can measure the anatomical site of obstruction. The post-surgical anatomical changes could correlate with a persistent OSAS, which would be helpful in selecting those patients who require a post surgical sleep study. The main goal of the study is to cuantify the changes in the oropharyngeal volume via acoustic pahryngometry after CPAP use, and also the changes after adentonsillectomy in children.
Detailed Description
The obstructive sleep apnea syndrome (OSAS) is defined as recurrent events of obstruction of the upper airway (with alteration of normal oxygenation, ventilation or sleep pattern). In children originates complications such as cognitive, cardiovascular and metabolic disorders and growth failure, which make its management imperative. It has a reported prevalence between 1 and 5%, highest between 2 and 8 years old, due to tonsil and adenoid hypertrophy, which causes obstruction of the upper airway, unlike the fat deposits of adults. This physiopathological cause of obstruction makes adenotonsillectomy the first line of management. This is a secure procedure, which still has an incidence of complications of 19%, (9.5% respiratory and 2.4% secondary bleeding). Those with OSAS present complications more frequently than those without7. Even though the surgery is considered succesful, up to 21.6% of those treated present persistence of the disease. Based on these results the American Academy of Pediatrics recommends considering polysomnography after surgery in those patients with high risk of persistence, such as obese children. The continuous positive airway pressure (CPAP) device provides a continuous pressure through a mask, acting as a pneumatic ferule which keeps the upper airway permeable; with a lower possibility of obstruction. The adherence of pediatric patients to CPAP has been reported between 6 and 65% (which is one of the reasons it's not considered the first line treatment), with an use of 2.1 to 8.2 hours per night, and an AIH (apnea-hypopnea index) between 2 and 6 per hour. In adult patients, a reduction in trans and post-surgical risk has been found, and therefore its pre-surgical use is recommended. In children it is one of the strategies used to reduce surgical risk in OSAS, even though its use is not recommended in any of the main clinical guides of management of children with OSAS. Its use has been described in children with severe illness, and in other studies it was used in 18% of patients, but its real effect in the probable complications has not been prospectively studied. In adult subjects, inflammation of upper airway has been reported, and it could play a role in the physiopathology of OSAS, with changes in the minimal sectional area and pharyngeal volume measured by MRI after use for 4 to 6 weeks of CPAP use. Albeit the physiopathology is not completely understood, it could be a consequence of the mechanical stress associated to obstruction of airflow, with the repeated trauma related with snore, jointly with the upper airway vibration and the suction from the collapse during the apneas the causes. CPAP eliminates respiratory events, which could cause a reduction in edema and inflammation. Acoustic pharyngometry is a non-invasive method which uses sound reflection to quickly measure the sectional area of the upper airway in function of the distance from the oral aperture. It can be adapted to its use in children, obtaining highly reproducible results, even though it is limited to those who can follow instructions. In adults a difference was found between the minimum oropharyngeal area and the mean area after 1 week of CPAP use, but not between 1 week and 6 months of use, with a return to basal after a 1 week of nonuse. In our center change in volume and transversal oropharyngeal area have been found with acoustic pharyngometry since the second week of use of CPAP, of 5% at 2 weeks and 6% at 4 weeks. In children changes after surgery have been found, with increase in the minimal sectional area and oropharyngeal volume, even though its correlation with persistent OSAS has not been studied. In order to study the changes in the upper airway after CPAP, acoustic pharyngometry will be performed before and after CPAP use, and 3 months after adenotonsillectomy to determinate the relation to persistent OSAS. The presurgical CPAP will be randomized in those children with diagnosis of mild to moderate OSAS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Child, Continuous Positive Airway Pressure, Adenoidectomy, Tonsillectomy
Keywords
Sleep Apnea, Obstructive, Child, Continuous Positive Airway Pressure, Perioperative management, Adenotonsillectomy, Acoustic pharyngometry

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All recruited children with diagnosis of mild to moderate OSAS will be randomized to suboptimal (CPAP at 4 cmH2O) or therapeutical (CPAP auto from 4 to 15 cmH2O) arms, from a predetermined list in two groups of 50, blocks of 10 patients. All patients with diagnosis of severe OSAS will receive therapeutic pressure, and are considered as part of a third arm not included in the sample size.
Masking
ParticipantInvestigator
Masking Description
The CPAP equipment will be programed by the technician, not knowing the children, the parents or the main researcher whether the pressure is suboptimal or therapeutic.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic
Arm Type
Experimental
Arm Description
Continuous positive airway pressure (CPAP) with automatic pressure from 4 to 15 cmH2O every night for one week, afterwards use of CPAP at the P90 of pressure determinated during automatic use for one week, via oronasal interface.
Arm Title
Suboptimal
Arm Type
Sham Comparator
Arm Description
Continuous positive airway pressure (CPAP) every night for two weeks at fixed pressure of 4 cmH2O, via oronasal interface.
Arm Title
Severe OSAS
Arm Type
Other
Arm Description
Continuous positive airway pressure (CPAP) with automatic pressure from 4 to 15 cmH2O every night for one week, afterwards use of CPAP at the P90 of pressure determinated during automatic use for one week, via oronasal interface.
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP)
Intervention Description
CPAP dispositives will be used by the children in the study every night for two weeks. Devices AutoSet Spirit from ResMed.
Primary Outcome Measure Information:
Title
Oropharyngeal volume postCPAP.
Description
Upper airway volume as measured by acoustic pharyngometry.
Time Frame
After two weeks of CPAP use.
Secondary Outcome Measure Information:
Title
Oropharyngeal volume post-surgery
Description
Upper airway volume as measured by acoustic pharyngometry.
Time Frame
Three months after adenotonsillectomy.
Title
OSA-18.
Description
Score in que quality of life questionnaire OSA-18.
Time Frame
After two weeks of CPAP use.
Title
OSA-18.
Description
Score in que quality of life questionnaire OSA-18.
Time Frame
Three months after adenotonsillectomy.
Title
Pediatric Sleep Questionnaire.
Description
Symptoms as described in the pediatric sleep questionnaire.
Time Frame
After two weeks of CPAP use.
Title
Pediatric Sleep Questionnaire.
Description
Symptoms as described in the pediatric sleep questionnaire.
Time Frame
Three months after adentonsillectomy.
Title
Surgical complications.
Description
Complications during or after the surgical procedure, as determined by checklist.
Time Frame
During and one month after surgery.
Other Pre-specified Outcome Measures:
Title
Residual respiratory disturbance index.
Description
Number of events of apnea, hypopnea per hour as measured by type 3 sleep monitor.
Time Frame
Three months after adenotonsillectomy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 4 and 14 years old. Both genders. Diagnosis of OSAS based on sleep study (respiratory polygraphy or polysomnography). Surgical treatment planned by the ORL department of the Institute of Respiratory Diseases of Mexico. Residents of the Metropolitan Area of Mexico City Parents and child accept to particpate in the study, singning informed consent and assent. Exclusion Criteria: Previous surgery in upper airway. Craneofacial malformation. Previous use of CPAP. Syndromatic patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angélica M Portillo-Vásquez, MD
Phone
+525554871700
Ext
5242
Email
ampvs1986@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Rogelio Pérez-Padilla, MD
Organizational Affiliation
Instituto Nacional Enfermedades Respiratorias
Official's Role
Study Director
Facility Information:
Facility Name
Instituto Nacional Enfermedades Respiratorias
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angélica M Portillo-Vásquez, MD
Phone
+525554871700
Ext
5242
Email
ampvs1986@gmail.com
First Name & Middle Initial & Last Name & Degree
Alejandra Castillo, Tc
Phone
+525554871700
Ext
5242
Email
ale_k_stillo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Angélica M Portillo-Vásquez, MD, MSc
First Name & Middle Initial & Last Name & Degree
José Rogelio Pérez-Padilla, MD, PhD
First Name & Middle Initial & Last Name & Degree
Armando R Castorena-Maldonado, MD, MSc
First Name & Middle Initial & Last Name & Degree
Luis Torre-Bouscoulet, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data from the study could be provided if solicited at the main author's e-mail adress.
Citations:
PubMed Identifier
26541535
Citation
Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.
Results Reference
background
PubMed Identifier
26391937
Citation
De Luca Canto G, Pacheco-Pereira C, Aydinoz S, Bhattacharjee R, Tan HL, Kheirandish-Gozal L, Flores-Mir C, Gozal D. Adenotonsillectomy Complications: A Meta-analysis. Pediatrics. 2015 Oct;136(4):702-18. doi: 10.1542/peds.2015-1283. Epub 2015 Sep 21.
Results Reference
background
PubMed Identifier
23118085
Citation
Kang KT, Hsu WC. Adenotonsillectomy outcomes in treatment of obstructive sleep apnea in children: a multicenter retrospective study. Am J Respir Crit Care Med. 2012 Nov 1;186(9):927; author reply 927-8. doi: 10.1164/ajrccm.186.9.927. No abstract available.
Results Reference
background
PubMed Identifier
18835648
Citation
Castorena-Maldonado A, Torre-Bouscoulet L, Meza-Vargas S, Vazquez-Garcia JC, Lopez-Escarcega E, Perez-Padilla R. Preoperative continuous positive airway pressure compliance in children with obstructive sleep apnea syndrome: assessed by a simplified approach. Int J Pediatr Otorhinolaryngol. 2008 Dec;72(12):1795-800. doi: 10.1016/j.ijporl.2008.08.016. Epub 2008 Oct 4.
Results Reference
background
PubMed Identifier
12045123
Citation
Monahan KJ, Larkin EK, Rosen CL, Graham G, Redline S. Utility of noninvasive pharyngometry in epidemiologic studies of childhood sleep-disordered breathing. Am J Respir Crit Care Med. 2002 Jun 1;165(11):1499-503. doi: 10.1164/rccm.200111-061OC.
Results Reference
background
PubMed Identifier
18815823
Citation
Corda L, Redolfi S, Montemurro LT, La Piana GE, Bertella E, Tantucci C. Short- and long-term effects of CPAP on upper airway anatomy and collapsibility in OSAH. Sleep Breath. 2009 May;13(2):187-93. doi: 10.1007/s11325-008-0219-1. Epub 2008 Sep 25.
Results Reference
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Effect of CPAP and Adenotonsillectomy in Upper Airway Volume of Children With OSAS

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