A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea
NCT ID: NCT07305168
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-05-02
2027-03-01
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Children with Obstructive Sleepapnea (OSA)
Children with OSA after (adeno)tonsillectomy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Polysomnography not available within 1 year before surgery
1 Year
18 Years
ALL
No
Sponsors
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University Hospital, Antwerp
OTHER
Responsible Party
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Vera Saldien
Principal Investigator
Principal Investigators
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Vera Saldien, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
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Antwerp University Hospital
Edegem, Antwerp, Belgium
Heim Pal Children's Hospital
Budapest, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Vera Saldien, MD, PhD
Role: primary
Joke De Wachter
Role: backup
Other Identifiers
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EDGE 004218
Identifier Type: -
Identifier Source: org_study_id