Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Not Applicable

Completed

• Conditions: Infants; Difficult Airway
• Interventions: Other: laryngoscopy with oxygen; Other: laryngoscopy without oxygen

• Registration Number: NCT01664234
• Lead Sponsor: Medical University of Vienna

Brief Summary

Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01-01
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-14
• Primary Completion: 2014-12-30
• Study Completion: 2014-12-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• infants (0-2) difficult airways

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Exclusion Criteria

• . Patients with American Society of Anesthesiologists physical status scores ≥3 congenital heart disease left-to-right shunting

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laryngoscopy with simultaneous insufflation of oxygen	laryngoscopy with oxygen	Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.
laryngoscopy without simultaneous oxygen insufflation	laryngoscopy without oxygen	Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.

Primary Outcome Measures

Name	Time	Method
time to oxygen saturation	Day 1	The randomized groups will be compared on time between laryngoscope (airtraq) insertion and reaching an oxygen saturation of 90%using a 2-tailed t-test or Wilcoxon-Mann-Whitney test, as appropriate.

Secondary Outcome Measures

Name	Time	Method
mean oxygenation comparison	Day 1	Randomized groups will be compared on mean oxygen saturation at the time of intubation using a 2-sample t-test

Trial Locations

Locations (1)

Medizinischen Universität Wien; 🇦🇹 Vienna, Borschkegasse, Austria