Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00992628
Collaborator
(none)
70
2
2
9
35
3.9

Study Details

Study Description

Brief Summary

Patients undergoing surgery or intensive care management often require a tube to be inserted into the trachea allowing lung ventilation. Usually a laryngoscope is used to allow visualisation of the larynx and facilitate intubation.

During direct laryngoscopy, the blade of the laryngoscope is inserted into the patient's mouth and the structures pulled upwards out of the line of vision. If visualisation is difficult, users often exert excess force on the tissues to obtain an adequate view. Generally the applied force is evaluated by the patient's stress response such as increased heart rate, blood pressure or plasma cortisol levels. These changes, while important, may be confounded by a variety of patient factors, as well as anaesthesia. An increased force may also be associated with tissue trauma, dental damage, and prolonged attempts.

The investigators' objective is to compare the force exerted on patient's tissues by the Macintosh laryngoscope and GlideScope video-laryngoscope. Video-laryngoscopes may be associated with the application of reduced force to the soft tissues of patients during intubation. While this is a common contention, it has not been proven. The GlideScope has a micro camera in the distal portion of the blade meaning a direct line of vision is not required. An adequate view can therefore be obtained with less displacement of tongue tissue. If the force exerted by the video laryngoscope is less, this would have beneficial implications by reducing stress response, neck movement, and trauma.

Condition or Disease Intervention/Treatment Phase
  • Device: Macintosh (direct vision) laryngoscope
  • Device: GlideScope videolaryngoscope (indirect vision)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Macintosh (direct vision) laryngoscope

Macintosh (direct vision) laryngoscope

Device: Macintosh (direct vision) laryngoscope
Macintosh (direct vision) laryngoscope

Active Comparator: GlideScope videolaryngoscope (indirect vision)

GlideScope videolaryngoscope (indirect vision)

Device: GlideScope videolaryngoscope (indirect vision)
GlideScope videolaryngoscope (indirect vision)

Outcome Measures

Primary Outcome Measures

  1. Forces generated during the intubation process using both laryngoscopes including peak and mean forces. [5-15minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • age > 18years

  • ASA 1-2

  • elective surgery

  • endotracheal intubation required (with non-depolarising muscle relaxant)

  • signed informed consent

Exclusion Criteria:
  • lack of informed consent

  • endotracheal intubation not required

  • ASA 3-5

  • symptomatic gastro-oesophageal reflux

  • rapid sequence intubation

  • other method of intubation indicated eg fibreoptic, awake tracheostomy

  • cervical spine instability

  • unstable hypertension

  • coronary artery disease

  • cerebral disease

  • COPD/asthma

  • oral/pharyngeal/laryngeal carcinoma

  • loose teeth/poor dentition

  • Macintosh laryngoscope >size 3 required

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto General Hospital, UHN Toronto Ontario Canada M5G 2C4
2 Toronto General Hospital, University Health Network Toronto Ontario Canada M5G 2C4

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Richard Cooper, MD, Toronto General Hospital, University Health Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00992628
Other Study ID Numbers:
  • UHN REB 09-0262-B
First Posted:
Oct 9, 2009
Last Update Posted:
Apr 15, 2011
Last Verified:
Apr 1, 2011

Study Results

No Results Posted as of Apr 15, 2011