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

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00664612
First received: April 18, 2008
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

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 Intervention
Trauma
Device: AirTraq

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Cervical Spine Movement [ Time Frame: Intubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Intubation [ Time Frame: Intubation ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Air Traq then Macintosh
Device: AirTraq
Laryngoscopy with AirTraq
Experimental: 2
Macintosh then AirTraq
Device: AirTraq
Laryngoscopy with AirTraq

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: T. P. Turkstra, University of Western Ontario
ClinicalTrials.gov Identifier: NCT00664612     History of Changes
Other Study ID Numbers: R-07-337, 13481
Study First Received: April 18, 2008
Last Updated: October 15, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Cervical Spine

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

ClinicalTrials.gov processed this record on July 22, 2014