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

NCT00992628 | Completed DMC

• 1 other identifier: UHN REB 09-0262-B
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Endotracheal Intubation; Laryngoscopy

Keywords

GlideScope Video Laryngoscope; Macintosh Direct Laryngoscope; Intubation; Applied Forces; Elective surgery where endotracheal intubation required

Outcome Measures

Primary Outcomes (1)

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

  5-15minutes

Study Arms (2)

Macintosh (direct vision) laryngoscope

ACTIVE COMPARATOR

Macintosh (direct vision) laryngoscope

Device: Macintosh (direct vision) laryngoscope

GlideScope videolaryngoscope (indirect vision)

ACTIVE COMPARATOR

GlideScope videolaryngoscope (indirect vision)

Device: GlideScope videolaryngoscope (indirect vision)

Interventions

Macintosh (direct vision) laryngoscope DEVICE

Macintosh (direct vision) laryngoscope

Macintosh (direct vision) laryngoscope

GlideScope videolaryngoscope (indirect vision) DEVICE

GlideScope videolaryngoscope (indirect vision)

GlideScope videolaryngoscope (indirect vision)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18years
• ASA 1-2
• elective surgery
• endotracheal intubation required (with non-depolarising muscle relaxant)
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Toronto General Hospital, UHN

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Interventions

Laryngoscopes

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Richard Cooper, MD

  Toronto General Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: October 9, 2009
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 15, 2011

Record last verified: 2011-04

Locations

CA (2)