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

May 1, 2009
April 14, 2011
July 2010
February 2011   (final data collection date for primary outcome measure)
Forces generated during the intubation process using both laryngoscopes including peak and mean forces. [ Time Frame: 5-15minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00992628 on ClinicalTrials.gov Archive Site
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Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope
Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Endotracheal Intubation
  • Laryngoscopy
  • Device: Macintosh (direct vision) laryngoscope
    Macintosh (direct vision) laryngoscope
  • Device: GlideScope videolaryngoscope (indirect vision)
    GlideScope videolaryngoscope (indirect vision)
  • Active Comparator: Macintosh (direct vision) laryngoscope
    Macintosh (direct vision) laryngoscope
    Intervention: Device: Macintosh (direct vision) laryngoscope
  • Active Comparator: GlideScope videolaryngoscope (indirect vision)
    GlideScope videolaryngoscope (indirect vision)
    Intervention: Device: GlideScope videolaryngoscope (indirect vision)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00992628
UHN REB 09-0262-B
Yes
Richard Cooper MD, Principal Investigator, Toronto General Hospital, University Health Network
University Health Network, Toronto
Not Provided
Principal Investigator: Richard Cooper, MD Toronto General Hospital, University Health Network
University Health Network, Toronto
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP