A Multicenter Retrospective Analysis of Postoperative Respiratory Complications in Children With Obstructive Sleepapnea (MRA PORC)

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Craniofacial Abnormalities; Neurologic Disorder; Adenotonsillectomy; Child Obesity; Postoperative Respiratory Complications; Children With Down Syndrome

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Vera Saldien, MD; Phone Number: 0032 38214788; Email: vera.saldien@uza.be
• Study Contact Backup: Name: Joke De Wachter; Phone Number: 0032 38213042; Email: joke.dewachter@uza.be

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Contact: Joke De Wachter; Phone Number: 0032 38213042; Email: joke.dewachter@uza.be
      • Contact: Vera Saldien, MD, PhD; Phone Number: 0032 38214788; Email: vera.saldien@uza.be
• Hungary
  • Budapest, Hungary, 1089
    • Completed
    • Heim Pal Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Children with Obstructive Sleepapnea (OSA); Children with OSA after (adeno)tonsillectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 hours postoperative

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Vera Saldien, MD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nutrition Disorders; Overnutrition; Body Weight; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Musculoskeletal Abnormalities; Congenital Abnormalities; Overweight; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Obesity; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Sleep Apnea, Obstructive; Pediatric Obesity; Nervous System Diseases; Craniofacial Abnormalities
• Other Study ID Numbers: EDGE 004218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No