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A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea

A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07305168
Acronym
MRA PORC
Enrollment
200
Registered
2025-12-26
Start date
2022-05-02
Completion date
2027-03-01
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenotonsillectomy, Child Obesity, Children With Down Syndrome, Craniofacial Abnormalities, Neurologic Disorder, Obstructive Sleep Apnea, Postoperative Respiratory Complications

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.

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.

Interventions

None listed

Sponsors

University Hospital, Antwerp
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
What is the prevalence of PORC in children undergoing surgical treatment for OSA and is the prevalence different according to the underlying comorbid condition24 hours postoperativeNumber of PORC

Countries

Belgium, Hungary

Contacts

Primary ContactVera Saldien, MD
vera.saldien@uza.be38214788
Backup ContactJoke De Wachter
joke.dewachter@uza.be38213042

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026