Effect of Different Positions During Extubation on Incidence of Hypoxemia in the Peri Extubation Period

NCT ID: NCT07231887

Last Updated: 2025-11-19

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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The most common disorder of sleep apnea in children is obstructive sleep apnea syndrome (OSAS), characterized by interrupted breathing and partial or complete obstruction of the upper airway, the main factor is the enlargement of the tonsils and adenoids in the pediatric pharynx. The clinical symptoms are snoring, and open-mouth breathing, then resulting in hypoventilation and hypoxemia. Due to the age of children, tonsillectomy and adenoidectomy are often performed under general anesthesia with tracheal intubation. The risk of hypoxemia and the degree of oxygen saturation reduction are bigger when the mask was removed in the supine position, and the most serious complication also occurred in the supine position. Therefore, the lateral position is preferable to the supine position for mask removal. There are few reports on the effect of different positions on complications related to tracheal extubation after tonsillectomy and adenoidectomy under general anesthesia in children with OSAS. In this study, we will 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.

Conditions

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Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group L (lateral position):

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

Group Type ACTIVE_COMPARATOR

positioning during peri-extubation

Intervention Type PROCEDURE

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 S (Sim' position):

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

Group Type ACTIVE_COMPARATOR

positioning during peri-extubation

Intervention Type PROCEDURE

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.

Interventions

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positioning during peri-extubation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* • Patient legal guardian refusal to participate in the study.

* Children with cardio-pulmonary disease
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shimaa Abbas Hassan

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shimaa A. Abbas, M.D.

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Shimaa A. Abbas

Role: CONTACT

01002953253 ext. 002

Mohammed R. Mahmoud

Role: CONTACT

01120792510‬‬‬‬‬‬ ext. 002

Other Identifiers

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ENT2025

Identifier Type: -

Identifier Source: org_study_id

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