STorz Against Glidescope Effectiveness (STAGE)

October 25, 2017 updated by: Michael Aziz, Oregon Health and Science University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation Time
Time Frame: 1 week
Intubation time is defined as the time from blade insertion to first return of end-tidal carbon dioxide
1 week
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.
1 week
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.
1 week
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

The University of Texas Health Science Center, Houston
University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimate)

July 3, 2012

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 62199040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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