Postoperative breathing problems after (adeno)tonsillectomy in children with sleep apnea
Official title: A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea
Run by University Hospital, Antwerp · NCT07305168 · Data updated 2026-11-12
See how common breathing problems are after (adeno)tonsillectomy in children with obstructive sleep apnea and which factors raise the risk.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Year to 18 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 2 sites (Edegem, Antwerp and 1 other locations) |
| Status | Recruiting |
| Started | May 2, 2022 |
| Main results expected | December 30, 2025 |
| Study ends | March 1, 2027 |
| Registry record updated | December 26, 2025 |
| Trial ID | NCT07305168 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children who underwent (adeno)tonsillectomy for OSA with a polysomnogram available within one year before surgery, including those with obesity or craniofacial syndromes, are the patients represented in this analysis.
✕Probably not a fit
Patients without a preoperative PSG within one year, those who had other airway surgeries as treatment for OSA, or adults are not represented and are unlikely to benefit from the study's conclusions.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This retrospective multicenter cohort combines anonymized prospective data collected at Antwerp University Hospital and Heim Pál National Pediatric Institute in Budapest on children who underwent (adeno)tonsillectomy for obstructive sleep apnea. The dataset includes otherwise healthy children and those with comorbidities such as obesity, craniofacial abnormalities, Down syndrome, and neurological conditions, with perioperative care recorded according to a predefined protocol. Investigators will determine the prevalence of postoperative respiratory complications and model associations with polysomnography metrics (oAHI, minimum oxygen saturation) and patient factors (age, comorbidities). The goal is to use identified risk factors to derive a postoperative management algorithm to guide monitoring intensity and disposition; all data are anonymized and no new patient contact is required.
Why it matters
Potential benefit: If successful, the results could help clinicians identify children at higher risk of breathing problems after tonsil surgery and tailor postoperative monitoring and care.
How similar studies have gone: Previous single-center studies have identified PSG and comorbidity risk factors for postoperative respiratory complications, but multicenter pooled datasets of this size are limited, making this approach partly novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * scheduled for (adeno)tonsillectomy as treatment for OSAS Exclusion Criteria: * other surgery than (adeno)tonsillectomy performed as treatment for OSAS * Polysomnography not available within 1 year before surgery
Where it's running
-
Antwerp University Hospital
Edegem, Antwerp, Belgium Recruiting -
Heim Pal Children's Hospital
Budapest, Hungary Completed
Study contacts
- Principal investigator: Vera Saldien, MD — University Hospital, Antwerp
- Study coordinator: Vera Saldien, MD
- Email: vera.saldien@uza.be
- Phone: 38214788
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.