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

Effect of Different Positions During Extubation on Incidence of Hypoxemia in the Peri Extubation Period of Pediatric OSAS Surgery Under General Anesthesia, Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypoxia
• Intervention / Treatment: Procedure: positioning during peri-extubation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 262
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shimaa A. Abbas; Phone Number: 002 01002953253; Email: Shimaa.abbas@med.aun.edu.eg
• Study Contact Backup: Name: Mohammed R. Mahmoud; Phone Number: 002 01120792510‬‬‬‬‬‬; Email: drabugabal2008@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of respiratory complications	Incidence of respiratory complications such as choking, laryngospasm, posterior tongue drop.	one hour after extubation

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Shimaa A. Abbas, M.D., Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia
• Other Study ID Numbers: ENT2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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