Actively Recruiting
A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea
Led by University Hospital, Antwerp · Updated on 2025-12-26
200
Participants Needed
2
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate postoperative respiratory complications (PORC) in children with obstructive sleep apnea (OSA) who undergo (adeno)tonsillectomy. It combines data from two centers: University Hospital Antwerp and Heim Pal National Pediatric Institute in Hungary. The study examines how common these complications are and whether they vary according to different health conditions such as obesity, craniofacial malformations, Down syndrome, or neurological disorders that affect airway muscle tone. Data come from a retrospective analysis of electronic health records originally collected in two prospective studies. These records include children who had (adeno)tonsillectomy for OSA, with postoperative care following a set protocol. The study looks at factors like the obstructive apnea-hypopnea index, oxygen levels during sleep studies, age at surgery, and presence of other health conditions to understand their relationship with PORC and to help develop a management plan. Participants' information was collected without needing additional consent because it uses existing anonymized data. Researchers assess the prevalence of PORC within 24 hours after surgery and analyze how different factors affect this risk. This study does not involve new treatments but reviews existing data to improve postoperative care. The study includes children aged 1 to 18 years who had (adeno)tonsillectomy for OSA, with follow-up limited to the immediate postoperative period.
CONDITIONS
Brief Title
A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for (adeno)tonsillectomy as treatment for obstructive sleep apnea
You will not qualify if you...
- Undergoing surgery other than (adeno)tonsillectomy for obstructive sleep apnea
- No polysomnography available within 1 year before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year before surgery
Participants undergo polysomnography to assess obstructive sleep apnea severity before surgery.
1 diagnostic visit (in-person)
Duration - 24 hours post-operative
Participants undergo (adeno)tonsillectomy and receive post-operative management according to a predefined treatment protocol.
Approximately 1 post-operative period
Duration - Retrospective observation period
Participants are observed for postoperative respiratory complications using existing electronic health record data.
Trial Site Locations
Total: 2 locations
1
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
2
Heim Pal Children's Hospital
Budapest, Hungary, 1089
Completed
Research Team
V
Vera Saldien, MD
J
Joke De Wachter
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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