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Clinical Trials/NCT01664234
NCT01664234
Completed
Not Applicable

Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Medical University of Vienna1 site in 1 country48 target enrollmentJanuary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infants
Sponsor
Medical University of Vienna
Enrollment
48
Locations
1
Primary Endpoint
time to oxygen saturation
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2012
End Date
December 30, 2014
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Olga Plattner

M.D.

Medical University of Vienna

Eligibility Criteria

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

Outcomes

Primary Outcomes

time to oxygen saturation

Time Frame: 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 Outcomes

  • mean oxygenation comparison(Day 1)

Study Sites (1)

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