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OpenTrials
Completed

NCT Number: NCT00992628

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto General Hospital, UHN, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macintosh (direct vision) laryngoscope

Device

Macintosh (direct vision) laryngoscope

GlideScope videolaryngoscope (indirect vision)

Device

GlideScope videolaryngoscope (indirect vision)

Primary outcomes

  1. Forces generated during the intubation process using both laryngoscopes including peak and mean forces.

    Time frame: 5-15minutes

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 9, 2009
Registry last updated
Apr 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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