NCT07231887

Brief Summary

Pediatric Obstructive Sleep Apnea Syndrome (OSAS) is common, often due to enlarged tonsils/adenoids. Tonsillectomy/adenoidectomy frequently performed under GA with tracheal intubation due to the age of children. Risk of hypoxemia and respiratory complications during the peri-extubation period is high.

Trial Health

65
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Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

November 14, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 14, 2025

Last Update Submit

November 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of hypoxemic events in the peri-extubation period

    Hypoxemic events which last \> 2 seconds after extubation will be recorded when Spo2 is less than 94% on room air.

    one hour after extubation

Secondary Outcomes (1)

  • Incidence of respiratory complications

    one hour after extubation

Study Arms (2)

Group L (lateral position):

ACTIVE COMPARATOR

ENT surgery patients positioned laterally with head in zero position after completion of surgery and before extubation till full recovery and discharge from PACU.

Procedure: positioning during peri-extubation

Group S (Sim' position):

ACTIVE COMPARATOR

ENT surgery patients positioned in semi-prone position after completion of surgery and before extubation till full recovery and discharge from PACU.

Procedure: positioning during peri-extubation

Interventions

investigate and compare whether the use of lateral position or semi-prone position impact on the occurrence of choking, agitation, decreased pulse oxygen saturation - (SpO2) and the oral and nasal secretions during the awakening period.

Group L (lateral position):Group S (Sim' position):

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 2-10 years
  • American Society of Anesthesiologists physical status classification (ASA) I - II
  • Patients scheduled for ENT procedures involving tonsillectomy, adenoidectomy or adenotonsillectomy

You may not qualify if:

  • Patient legal guardian refusal to participate in the study.
  • Children with cardio-pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shimaa A. Abbas, M.D.

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 17, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share