Observing respiratory complications in children after sleep apnea surgery
Study of Postoperative Respiratory Complications in Children With Obstructive Sleep Apnea.
This study looks at how often kids with sleep apnea have breathing problems after surgery and how their other health issues might affect this.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT05308108 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children with obstructive sleep apnea (OSA) who are scheduled for adenotonsillectomy, the primary surgical treatment for this condition. It aims to investigate the incidence of postoperative respiratory complications (PORC) and how these complications relate to various co-morbidities such as obesity and Down syndrome. The study seeks to develop a management flowchart for postoperative care based on factors like age and severity of OSA. Children will be evaluated preoperatively by an anesthesiologist to ensure they meet inclusion criteria and to assess their health status.
Who should consider this trial
Good fit: Ideal candidates for this study are children scheduled for adenotonsillectomy as treatment for obstructive sleep apnea.
Not a fit: Patients undergoing surgeries other than adenotonsillectomy for obstructive sleep apnea or those without recent polysomnography results may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for children undergoing surgery for obstructive sleep apnea, potentially reducing postoperative complications.
How similar studies have performed: While there are guidelines from various organizations regarding postoperative care, this study addresses a gap in consensus and aims to provide new insights, making it a novel approach.
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
- Antwerp University Hospital — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Principal investigator: Vera Saldien, MD,PhD — University Hospital, Antwerp
- Study coordinator: Vera Saldien, MD, PhD
- 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.