A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea

NCT07305168 | Recruiting

• 1 other identifier: EDGE 004218
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 2

Brief Summary

This retrospective observational study aims to evaluate postoperative respiratory complications (PORC) after (adeno)tonsillectomy in children with OSA. In order to increase the number of patients available for analysis, we will merge data collected at UZA with data collected at the the Department of Sleep Laboratory and Sleep Surgery at the Heim Pal National Pediatric Institute, Hungary. These colleagues performed an identical prospective data collection.

Conditions

Obstructive Sleep Apnea; Adenotonsillectomy; Child Obesity; Craniofacial Abnormalities; Children With Down Syndrome; Neurologic Disorder; Postoperative Respiratory Complications

Outcome Measures

Primary Outcomes (1)

• What is the prevalence of PORC in children undergoing surgical treatment for OSA and is the prevalence different according to the underlying comorbid condition

  Number of PORC

  24 hours postoperative

Study Arms (1)

Children with Obstructive Sleepapnea (OSA)

Children with OSA after (adeno)tonsillectomy

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

children with or without co-morbidities undergoing (adeno)tonsillectomy for OSAS during time frame of the study period

You may qualify if:

• scheduled for (adeno)tonsillectomy as treatment for OSAS

You may not qualify if:

• other surgery than (adeno)tonsillectomy performed as treatment for OSAS
• Polysomnography not available within 1 year before surgery

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (2)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

Heim Pal Children's Hospital

Budapest, 1089, Hungary

COMPLETED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pediatric Obesity; Craniofacial Abnormalities; Nervous System Diseases

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Vera Saldien, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vera Saldien, MD

CONTACT

38214788; vera.saldien@uza.be

Joke De Wachter

CONTACT

38213042; joke.dewachter@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 26, 2025
• Study Start: May 2, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

HU (1); BE (1)