Clinical Trials Directory

Trials / Completed

CompletedNCT01664234

Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Medical University of Vienna · Academic / Other
Sex
All
Age
1 Month – 2 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERlaryngoscopy with oxygenPatients 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.
OTHERlaryngoscopy without oxygenPatients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.

Timeline

Start date
2012-01-01
Primary completion
2014-12-30
Completion
2014-12-30
First posted
2012-08-14
Last updated
2023-08-31

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT01664234. Inclusion in this directory is not an endorsement.