Clinical trial NCT00992628: Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope
Official title: Measurement of Forces Applied Using a Macintosh Direct Laryngoscope Compared to GlideScope Video Laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Laryngoscopy
Keywords: GlideScope Video Laryngoscope
Macintosh Direct Laryngoscope
Intubation
Applied Forces
Elective surgery where endotracheal intubation required
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Forces generated during the intubation process using both laryngoscopes including peak and mean forces.
timeFrame: 5-15minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, UHN
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital, University Health Network
name: Richard Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References: