STorz Against Glidescope Effectiveness (STAGE)
This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Comparative Effectiveness of the C-MAC D-blade to Glidescope Videolaryngoscope in the Predicted Difficult Airway|
- Intubation success rate [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide
- Intubation time [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide
- Laryngeal view [ Time Frame: 1 week ] [ Designated as safety issue: No ]Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team.
- Use of adjuncts [ Time Frame: 1 week ] [ Designated as safety issue: No ]The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.
- Complications [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]Patients will be examined for evidence of mucosal or dental injury upon intervention. Patients will be asked if they have a sore throat in the recovery room, and their medical record will be reviewed to determine if any other airway related complications were observed by the clinical team including the need for reintubation or steroid administration to reduce swelling.
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||September 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: C-MAC
Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation
Active Comparator: Glidescope
Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632683
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|