Postoperative breathing problems after (adeno)tonsillectomy in children with sleep apnea
A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea
University Hospital, Antwerp · NCT07305168
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Antwerp (other) |
| Locations | 2 sites (Edegem, Antwerp and 1 other locations) |
| Trial ID | NCT07305168 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Edegem, Antwerp and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea, Postoperative Respiratory Complications, Adenotonsillectomy, Child Obesity, Craniofacial Abnormalities, Children With Down Syndrome, Neurologic Disorder