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STorz Against Glidescope Effectiveness (STAGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632683
Recruitment Status : Completed
First Posted : July 3, 2012
Results First Posted : October 7, 2014
Last Update Posted : November 30, 2017
University of Iowa
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Michael Aziz, Oregon Health and Science University

Brief 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.

Condition or disease Intervention/treatment Phase
Difficult Airway Device: C-MAC Device: Glidescope Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparative Effectiveness of the C-MAC D-blade to Glidescope Videolaryngoscope in the Predicted Difficult Airway
Study Start Date : May 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Intubation Success Rate [ Time Frame: 1 week ]
    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 :
  1. Intubation Time [ Time Frame: 1 week ]
    Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide

  2. Graded Score of Laryngeal View Achieved [ Time Frame: 1 week ]
    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.

  3. Number of Particpants Requiring Adjuncts to Assist Intubation [ Time Frame: 1 week ]
    The need for use of a gum-elastic bougie or external laryngeal manipulation to facilitate tube placement will be measured by the study team.

  4. Number of Participants With Observed Complications [ Time Frame: 1 week ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01632683

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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
University of Iowa
The University of Texas Health Science Center, Houston
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Responsible Party: Michael Aziz, Associate Professor, Oregon Health and Science University Identifier: NCT01632683    
Other Study ID Numbers: 62199040
First Posted: July 3, 2012    Key Record Dates
Results First Posted: October 7, 2014
Last Update Posted: November 30, 2017
Last Verified: October 2017
Keywords provided by Michael Aziz, Oregon Health and Science University:
difficult airway
video laryngoscopy