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

A

Assiut University

Status

Not yet enrolling

Conditions

Hypoxia

Treatments

Procedure: positioning during peri-extubation

Study type

Interventional

Funder types

Other

Identifiers

NCT07231887
ENT2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

262 estimated patients

Sex

All

Ages

2 to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

262 participants in 2 patient groups

Group L (lateral position):
Active Comparator group
Description:
ENT surgery patients positioned laterally with head in zero position after completion of surgery and before extubation till full recovery and discharge from PACU.
Treatment:
Procedure: positioning during peri-extubation
Group S (Sim' position):
Active Comparator group
Description:
ENT surgery patients positioned in semi-prone position after completion of surgery and before extubation till full recovery and discharge from PACU.
Treatment:
Procedure: positioning during peri-extubation

Trial contacts and locations

0

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Central trial contact

Shimaa A. Abbas; Mohammed R. Mahmoud

Data sourced from clinicaltrials.gov

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