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Comparison of AirTraq Laryngoscope to Macintosh Laryngoscope for Intubation of Patients With Potential Cervical Spine Injury

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ClinicalTrials.gov Identifier: NCT00664612
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : October 16, 2008
Sponsor:
Information provided by:
Lawson Health Research Institute

Brief Summary:

Intubation is frequently required for trauma patients as part of the resuscitative effort. When the stability of the cervical spine is unknown, the potential for spinal cord damage during intubation is significant; the question of the safest intubating technique has not been resolved. Previous Studies have evaluated Macintosh Laryngoscopy, Bullard Laryngoscope, face mask ventilation, fibre-optic guided oral and nasal intubation, esophageal Combitube®, Laryngeal Mask Airway® (LMA), and Intubating Laryngeal Mask Airway® (ILMA) use with respect to cervical spine movement. Our previous study evaluated the Intubating Lighted Stylet (Lightwand®) and GlideScope® versus the Macintosh Laryngoscope.

Another method of securing endotracheal intubation, approved and in routine use, is the AirTraq® videolaryngoscope (ProMedic, Inc, Bonita Springs, FL, USA). The AirTraq videolaryngoscope is a videolaryngoscope with an external video display of the glottic opening and an endotracheal tube track to guide the ETT through the vocal cords (www.airtraq.com). When a clear view of the vocal cords is obtained, the endotracheal tube may be advanced into the trachea. This technique can be performed rapidly and safely and there is the perception that it involves less cervical spine movement than direct laryngoscopy.

We propose to study the AirTraq videolaryngoscope to determine if its use would result in reduced cervical spine movement during intubation.


Condition or disease Intervention/treatment Phase
Trauma Device: AirTraq Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comparison of AirTraq Laryngoscope to Macintosh Laryngoscope for Intubation of Patients With Potential Cervical Spine Injury
Study Start Date : January 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Air Traq then Macintosh
Device: AirTraq
Laryngoscopy with AirTraq
Experimental: 2
Macintosh then AirTraq
Device: AirTraq
Laryngoscopy with AirTraq



Primary Outcome Measures :
  1. Cervical Spine Movement [ Time Frame: Intubation ]

Secondary Outcome Measures :
  1. Time to Intubation [ Time Frame: Intubation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective non-cardiac surgery patients requiring intubation for the surgery.
  • (Cardiac surgery uses TEE; there would not be space for the fluoroscopy machine.)
  • ASA 1-3
  • Body Mass Index (BMI) < 35

Exclusion Criteria:

  • patients with previous neck surgery or unstable C-spine
  • patients with Reflux disease (GERD)
  • patients who are or may be pregnant

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 ClinicalTrials.gov identifier (NCT number): NCT00664612


Locations
Canada, Ontario
University of Western Ontario
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Timothy P Turkstra, MD University of Western Ontario, Canada

Responsible Party: T. P. Turkstra, University of Western Ontario
ClinicalTrials.gov Identifier: NCT00664612     History of Changes
Other Study ID Numbers: R-07-337
13481
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: October 16, 2008
Last Verified: October 2008

Keywords provided by Lawson Health Research Institute:
Cervical Spine

Additional relevant MeSH terms:
Spinal Injuries
Back Injuries
Wounds and Injuries