A Multicenter Retrospective Analysis of Postoperative Res... | NCT07305168

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

NCT07305168

Sponsor

University Hospital, Antwerp

Status

Recruiting

Last Update Posted

Dec 26, 2025Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Belgium
Hungary

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2022Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Mar 1, 2027Estimated

First Submitted Date

Nov 17, 2025

First Submission Date that Met QC Criteria

Dec 11, 2025

First Posted Date

Dec 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2025

Last Update Posted Date

Dec 26, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vera Saldien, Principal Investigator, University Hospital, AntwerpPrincipal Investigator

Lead Sponsor

University Hospital, AntwerpOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Keywords

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with Obstructive Sleepapnea (OSA)		Children with OSA after (adeno)tonsillectomy

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vera Saldien, MD	Contact	38214788	0032	vera.saldien@uza.be
Joke De Wachter	Contact	38213042	0032	joke.dewachter@uza.be

Overall Officials

Name	Affiliation	Role
Vera Saldien, MD	University Hospital, Antwerp	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Antwerp University Hospital	Recruiting	Edegem	Antwerp	2650	Belgium

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D020181	Sleep Apnea, Obstructive
D063766	Pediatric Obesity
D019465	Craniofacial Abnormalities
D009422	Nervous System Diseases

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities