STorz Against Glidescope Effectiveness

Difficult Airway Clinical Trial

— STAGE  

Official title:

Comparative Effectiveness of the C-MAC D-blade to Glidescope Videolaryngoscope in the Predicted Difficult Airway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632683
• Other study ID #: 62199040
• Status: Completed
• Phase: N/A
• First received: June 14, 2012
• Last updated: October 25, 2017
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: October 2017
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• adult 18 years of age

• Mallampati classification scale score of 3 or 4

• Neck circumference greater than 40cm for males, 38 cm for females

• mouth opening less than 3cm, but greater than 2cm

Exclusion Criteria:

• children

• prisoners

• history of easy intubation (success on first attempt with direct laryngoscopy)

• known unstable cervical spine injury

• emergency surgery

• nasal intubation route

• planned awake technique

Related Conditions & MeSH terms

• Difficult Airway

Intervention

Device:
• C-MAC
C-MAC arm
• Glidescope
Glidescope arm

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	The University of Texas Health Science Center, Houston, University of Iowa

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aziz MF, Dillman D, Fu R, Brambrink AM. Comparative effectiveness of the C-MAC video laryngoscope versus direct laryngoscopy in the setting of the predicted difficult airway. Anesthesiology. 2012 Mar;116(3):629-36. doi: 10.1097/ALN.0b013e318246ea34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation Success Rate	Success rate is defined as a single blade insertion with successful tracheal tube placement confirmed by return of end-tidal carbon dioxide	1 week
Secondary	Intubation Time	Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide	1 week
Secondary	Graded Score of Laryngeal View Achieved	Laryngeal view is defined by the modified Cormack and Lehane scale (1-4) and is assessed by the clinician and the study team. Grade 1 is considered to be a good view while grade 4 is considered to be a poor view.	1 week
Secondary	Number of Particpants Requiring Adjuncts to Assist Intubation	The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.	1 week
Secondary	Number of Participants With Observed Complications	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.	1 week