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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03169491
• Date of registration: 25/05/2017
• Prospective Registration: No
• Primary sponsor: Instituto Nacional de Enfermedades Respiratorias
• Public title: Effect of CPAP and Adenotonsillectomy in Upper Airway Volume of Children With OSAS
• Scientific 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
• Date of first enrolment: July 4, 2016
• Target sample size: 150
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03169491
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Mexico

Contacts

• Name: Angélica M Portillo-Vásquez, MD

• Name: Angélica M Portillo-Vásquez, MD

• Name: José Rogelio Pérez-Padilla, MD
• Affiliation: Instituto Nacional Enfermedades Respiratorias

Key inclusion & exclusion 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.



Age minimum: 4 Years
Age maximum: 14 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sleep Apnea, Obstructive

Tonsillectomy

Adenoidectomy

Child

Continuous Positive Airway Pressure

Intervention(s)

Device: Continuous positive airway pressure (CPAP)

Primary Outcome(s)

Oropharyngeal volume postCPAP. [Time Frame: After two weeks of CPAP use.]

Secondary Outcome(s)

Pediatric Sleep Questionnaire. [Time Frame: Three months after adentonsillectomy.]

OSA-18. [Time Frame: Three months after adenotonsillectomy.]

Surgical complications. [Time Frame: During and one month after surgery.]

Pediatric Sleep Questionnaire. [Time Frame: After two weeks of CPAP use.]

Oropharyngeal volume post-surgery [Time Frame: Three months after adenotonsillectomy.]

OSA-18. [Time Frame: After two weeks of CPAP use.]

Secondary ID(s)

C12-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors