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Not yet recruiting NCT07231887

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

No phase Interventional Hypoxia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: positioning during peri-extubation.
Who it may be relevant to
Registry conditions: Hypoxia. Basic parameters: 2 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • 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.

Primary outcome measures

  • Incidence of hypoxemic events in the peri-extubation period [Time frame: one hour after extubation]
Secondary outcome measures (1)
  • Incidence of respiratory complications [Time frame: one hour after extubation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07231887 · ENT2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗