NCT05308108

Brief Summary

Adenotonsillectomy is the first line surgical treatment for children with Obstructive Sleep apnea Syndrome (OSAS). Postoperative respiratory complications (PORC) may occur and are often related to co-morbidities. Despite guidelines from different scientific groups, there is no consensus on the monitoring requirements and management of PORC in these children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

March 24, 2022

Last Update Submit

January 26, 2026

Conditions

Obstructive Sleep ApneaChild, OnlySurgery

Outcome Measures

Primary Outcomes (2)

  • The incidence of PORC related to age in children with/without comorbidities undergoing (adeno)tonsillectomy

    Number of PORC

    24hr postoperative period

  • The incidence of PORC related to OSAS severity in children with/without comorbidities undergoing (adeno)tonsillectomy

    Number of PORC

    24 hr postoperative period

Secondary Outcomes (1)

  • Development of a flow chart for postoperative monitoring of PORC in children with OSA

    2 years

Study Arms (1)

Children with Obstructive Sleepapnea

Procedure: (Adeno)tonsillectomy

Interventions

(Adeno)tonsillectomyPROCEDURE

registration of PORC in children with OSAS after (adeno)tonsillectomy

Children with Obstructive Sleepapnea

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • scheduled for (adeno)tonsillectomy as treatment for OSAS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Vera Saldien, MD,PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 1, 2022

Study Start

May 2, 2022

Primary Completion

January 7, 2026

Study Completion

January 7, 2026

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

BE(1)