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RecruitingNCT07305168MRA PORCUpdated Dec 26, 2025

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

An observational study in Obstructive Sleep Apnea, Postoperative Respiratory Complications and Adenotonsillectomy, sponsored by University Hospital, Antwerp. Recruiting at 2 sites in 2 countries. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by University Hospital, Antwerp · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Obstructive Sleep Apnea
  • Postoperative Respiratory Complications
  • Adenotonsillectomy
  • Child Obesity
  • Craniofacial Abnormalities
  • Children With Down Syndrome
  • Neurologic Disorder
03

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

children with or without co-morbidities undergoing (adeno)tonsillectomy for OSAS during time frame of the study period

Inclusion criteria

  • scheduled for (adeno)tonsillectomy as treatment for OSAS

Exclusion criteria

Exclusion Criteria:

  • other surgery than (adeno)tonsillectomy performed as treatment for OSAS
  • Polysomnography not available within 1 year before surgery
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Children with Obstructive Sleepapnea (OSA)

    Children with OSA after (adeno)tonsillectomy

05

What researchers measure

Primary outcomes

  1. What is the prevalence of PORC in children undergoing surgical treatment for OSA and is the prevalence different according to the underlying comorbid condition

    Number of PORC

    Time frame: 24 hours postoperative

06

Study locations

1 of 2 sites recruiting
  • Antwerp University Hospital
    Edegem, Antwerp 2650, Belgium
    Recruiting
  • Heim Pal Children's Hospital
    Budapest, 1089, Hungary
    Completed
07

Registry details

Key details

Study ID
NCT07305168
Lead sponsor
University Hospital, Antwerp
Responsible party
Vera Saldien (Principal Investigator, University Hospital, Antwerp) — Principal investigator
First posted
Dec 26, 2025
Start date
May 2, 2022
Primary completion
Dec 30, 2025 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Dec 26, 2025

Study contacts

Vera Saldien, MD
Contact
vera.saldien@uza.be
38214788 ext. 0032
Joke De Wachter
Contact
joke.dewachter@uza.be
38213042 ext. 0032
Vera Saldien, MD
principal investigator · University Hospital, Antwerp

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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