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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00992628
Other study ID # UHN REB 09-0262-B
Secondary ID
Status Completed
Phase N/A
First received May 1, 2009
Last updated April 14, 2011
Start date July 2010
Est. completion date April 2011

Study information

Verified date April 2011
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date April 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Macintosh (direct vision) laryngoscope
Macintosh (direct vision) laryngoscope
GlideScope videolaryngoscope (indirect vision)
GlideScope videolaryngoscope (indirect vision)

Locations

Country Name City State
Canada Toronto General Hospital, UHN Toronto Ontario
Canada Toronto General Hospital, University Health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forces generated during the intubation process using both laryngoscopes including peak and mean forces. 5-15minutes No
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