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

NCT03169491 | Unknown FDA Device

• 1 other identifier: C12-16
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive; Child; Continuous Positive Airway Pressure; Adenoidectomy; Tonsillectomy

Keywords

Sleep Apnea, Obstructive; Child; Continuous Positive Airway Pressure; Perioperative management; Adenotonsillectomy; Acoustic pharyngometry

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal volume postCPAP.

  Upper airway volume as measured by acoustic pharyngometry.

  After two weeks of CPAP use.

Secondary Outcomes (6)

• Oropharyngeal volume post-surgery

  Three months after adenotonsillectomy.

• OSA-18.

  After two weeks of CPAP use.

• OSA-18.

  Three months after adenotonsillectomy.

• Pediatric Sleep Questionnaire.

  After two weeks of CPAP use.

• Pediatric Sleep Questionnaire.

  Three months after adentonsillectomy.

Other Outcomes (1)

• Residual respiratory disturbance index.

  Three months after adenotonsillectomy.

Study Arms (3)

Therapeutic

EXPERIMENTAL

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.

Device: Continuous positive airway pressure (CPAP)

Suboptimal

SHAM COMPARATOR

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

Device: Continuous positive airway pressure (CPAP)

Severe OSAS

OTHER

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.

Device: Continuous positive airway pressure (CPAP)

Interventions

Continuous positive airway pressure (CPAP) DEVICE

CPAP dispositives will be used by the children in the study every night for two weeks. Devices AutoSet Spirit from ResMed.

Severe OSAS; Suboptimal; Therapeutic

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Enfermedades Respiratorias: lead

Study Sites (1)

Instituto Nacional Enfermedades Respiratorias

Mexico City, 14080, Mexico

RECRUITING

Related Publications (6)

• 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.

  PMID: 26541535 BACKGROUND

• 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.

  PMID: 26391937 BACKGROUND

• 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.

  PMID: 23118085 BACKGROUND

• 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.

  PMID: 18835648 BACKGROUND

• 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.

  PMID: 12045123 BACKGROUND

• 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.

  PMID: 18815823 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• José Rogelio Pérez-Padilla, MD

  Instituto Nacional Enfermedades Respiratorias

  STUDY DIRECTOR

Central Study Contacts

Angélica M Portillo-Vásquez, MD

CONTACT

+525554871700; ampvs1986@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 30, 2017
• Study Start: July 4, 2016
• Primary Completion: August 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 12, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)