NCT00664612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

Enrollment Period

4 months

First QC Date

April 18, 2008

Last Update Submit

October 15, 2008

Conditions

Keywords

Cervical Spine

Outcome Measures

Primary Outcomes (1)

  • Cervical Spine Movement

    Intubation

Secondary Outcomes (1)

  • Time to Intubation

    Intubation

Study Arms (2)

1

EXPERIMENTAL

Air Traq then Macintosh

Device: AirTraq

2

EXPERIMENTAL

Macintosh then AirTraq

Device: AirTraq

Interventions

AirTraqDEVICE

Laryngoscopy with AirTraq

12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Ontario

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Timothy P Turkstra, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 23, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations