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STorz Against Glidescope Effectiveness (STAGE)

This study is currently recruiting participants.
Verified May 2013 by Oregon Health and Science University
Sponsor:
Collaborators:
University of Iowa
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Michael Aziz, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01632683
First received: June 14, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Difficult Airway
 Device: C-MAC
Device: Glidescope

Study Type: Interventional
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

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1100
Study Start Date: May 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: C-MAC
Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation
 Device: C-MAC
C-MAC arm
Active Comparator: Glidescope
Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation
 Device: Glidescope
Glidescope arm

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632683

Contacts
Contact: Michael Aziz, MD 5034945581 azizm@ohsu.edu
Contact: Katherine Parker, BSN 5034945224 parkerk@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Michael Aziz, MD     503-494-5581     azizm@ohsu.edu    
Sponsors and Collaborators
Oregon Health and Science University
University of Iowa
The University of Texas Health Science Center, Houston
  More Information

Publications:

Responsible Party: Michael Aziz, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01632683     History of Changes
Other Study ID Numbers: 62199040
Study First Received: June 14, 2012
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
difficult airway
video laryngoscopy

ClinicalTrials.gov processed this record on May 22, 2013