Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: laryngoscopy with simultaneous insufflation of 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. |
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.
|
| Placebo Comparator: laryngoscopy without simultaneous oxygen insufflation 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. |
Other: laryngoscopy without oxygen
Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medizinischen Universität Wien | Vienna | Borschkegasse | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
- Principal Investigator: Olga Plattner, M.D., Medizinischen Universität Wien Vienna
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ECS 1178/2012