Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:48 PM
Study NCT ID:
NCT07305168
Status:
RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea
Sponsor:
University Hospital, Antwerp
Organization:
Study Overview
Official Title:
A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRA PORC
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.
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.
Detailed Description:
This is a retrospective, multicenter cohort study using anonymized electronic health record data collected in a prospective study (PORC -EDGE 2364) performed at UZA and an identical prospective data collection performed by collegues at Department of Sleep Laboratory and Sleep surgery at Heim Pal National Pediatric Institute at Budapest.Data are collected from otherwise healthy children and children with varying comorbidities undergoing (adeno)-tonsillecty for Obstructive Sleepapnea (OSAS). Per-postoperative management was carried out according to a predefined treatment protocol.
As this study uses existing data, no informed consent was required. The aim of the current project is to answer the following questions.
* What is the prevalence of Postoperative Respiratory Complications (PORC) in children undergoing surgical treatment for OSA and is the prevalence different according to the underlying comorbid condition (i.e obesity, craniofacial malformation, syndromes Down syndrome, neurological conditions affecting upper airway muscle tone)?
* Which factors are associated with the occurrence of PORC (Polysomnogram (PSG) related factors such as obstructive Apnea-Hypopnea Index (oAHI), minimum oxygen saturation during PSG, and patient related factors such as age at time of surgery, presence of a comorbidity)?
* Is it possible to develop a management algorithm for postoperative management based upon the risk factors for PORC above.
As this study uses existing data, no informed consent was required. The aim of the current project is to answer the following questions.
* What is the prevalence of Postoperative Respiratory Complications (PORC) in children undergoing surgical treatment for OSA and is the prevalence different according to the underlying comorbid condition (i.e obesity, craniofacial malformation, syndromes Down syndrome, neurological conditions affecting upper airway muscle tone)?
* Which factors are associated with the occurrence of PORC (Polysomnogram (PSG) related factors such as obstructive Apnea-Hypopnea Index (oAHI), minimum oxygen saturation during PSG, and patient related factors such as age at time of surgery, presence of a comorbidity)?
* Is it possible to develop a management algorithm for postoperative management based upon the risk factors for PORC above.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: