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NCT01664234 Clinical Trial

Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Difficult Airway Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01664234
Other study ID # ECS 1178/2012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2012
Est. completion date December 30, 2014

Study information
Verified date August 2023
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date December 30, 2014
Est. primary completion date December 30, 2014
Accepts healthy volunteers No
Gender All
Age group 1 Month to 2 Years
Eligibility Inclusion Criteria: - infants (0-2) difficult airways Exclusion Criteria: - . Patients with American Society of Anesthesiologists physical status scores =3 congenital heart disease left-to-right shunting

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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 oxygen
Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.

Locations
Country Name City State
Austria Medizinischen Universität Wien Vienna Borschkegasse

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to oxygen saturation 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. Day 1
Secondary mean oxygenation comparison Randomized groups will be compared on mean oxygen saturation at the time of intubation using a 2-sample t-test Day 1
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