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NCT Number: NCT07305168

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: 24 hours postoperative

    Number of PORC

Study contacts

Contact information is provided by the study sponsor or research team.

Joke De Wachter

CONTACT

[email protected]

38213042 ext. 0032

Vera Saldien, MD

CONTACT

[email protected]

38214788 ext. 0032

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Acronym: MRA PORC

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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