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
| Type | Name | Description |
|---|---|---|
| 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. |
| OTHER | laryngoscopy without oxygen | Patients 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.