Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators

Airway Clinical Trial

Official title:

Comparison of GlideScope-Specific Rigid Stylet to Standard Malleable Stylet for GlideScope Intubation by Novice Operators

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884754
• Other study ID #: R-08-594
• Secondary ID: 15520
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: December 13, 2010
• Start date: March 2009
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Patients presenting for elective surgery requiring tracheal intubation will be randomized to one of two different endotracheal tube (ETT) stylets. The intubation will be done with a GlideScope videolaryngoscope by a novice operator. The primary outcome is time to intubation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• any adult patient scheduled for elective surgery.

• ETT is indicated for the procedure in the opinion of the attending anesthesiologist.

• any operator who has performed = 10 GlideScope intubations.

Exclusion Criteria:

• any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.

• Patient with known cervical spine abnormalities.

• any patients with known or probable difficult airways. (This rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).

• any patient requiring rapid sequence induction.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Airway

Intervention

Device:
• GlideScope rigid stylet
Patients will be intubated either with a rigid stylet meant to be used with the GlideScope, or with a standard malleable stylet used with other modalities of intubation.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Intubation (Seconds)		30-150 seconds (anticipated)	No