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

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00992628
First received: May 1, 2009
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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 Intervention
Endotracheal Intubation
Laryngoscopy
Device: Macintosh (direct vision) laryngoscope
Device: GlideScope videolaryngoscope (indirect vision)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Forces generated during the intubation process using both laryngoscopes including peak and mean forces. [ Time Frame: 5-15minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00992628

Locations
Canada, Ontario
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4
Toronto General Hospital, UHN
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Richard Cooper, MD Toronto General Hospital, University Health Network
  More Information

No publications provided

Responsible Party: Richard Cooper MD, Principal Investigator, Toronto General Hospital, University Health Network
ClinicalTrials.gov Identifier: NCT00992628     History of Changes
Other Study ID Numbers: UHN REB 09-0262-B
Study First Received: May 1, 2009
Last Updated: April 14, 2011
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
GlideScope Video Laryngoscope
Macintosh Direct Laryngoscope
Intubation
Applied Forces
Elective surgery where endotracheal intubation required

ClinicalTrials.gov processed this record on September 16, 2014