Intubation Clinical Trial
Official title:
Comparison of Flex-It Stylet to Malleable Stylet for GlideScope Intubation: A Randomized Controlled Trial
Verified date | July 2009 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
Patients presenting for elective surgery requiring tracheal intubation will be randomized to
one of two different ETT stylets. The primary outcome is time to intubation.
The null hypothesis is that there will be no difference.
The GlideScope video laryngoscope (Verathon) is a widely used intubating device that uses a
high-resolution camera embedded into a plastic laryngoscope blade. An LED provides
illumination. The GlideScope often provides a good laryngoscopic view, but passing the
endotracheal tube (ETT) through the vocal cords is sometimes difficult. Because of the 60
degree anterior curvature of the GlideScope's blade, ETT's must have stylets inserted so
that the ETT distal tip can be positioned anteriorly. Various authors have recommended
different angles of the ETT to optimally place it into the trachea, including matching the
GlideScope's 60 degree angle, or configuring the ETT with a 90 degree bend. Previous studies
demonstrated that 90 degree sharp bend was both faster and subjectively easier in a
heterogeneous group of intubators. With the introduction of the Flex-It stylet by Parker
Medical, the question arises as to the the best configuration of stylet for the ETT.
Therefore, this prospective, randomized, single-blinded trial is proposed.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. * Any adult patient scheduled for elective surgery. 2. ETT is indicated for the procedure in the opinion of the attending anesthesiologist. 3. Any operator who has performed = 10 GlideScope intubations. Exclusion Criteria: 1. Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist. 2. * Patient with known cervical spine abnormalities. 3. * 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). 4. Any patient requiring rapid sequence induction. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Center | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute | London Health Sciences Centre, St. Joseph Hospital Health Center |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Intubation | Prospective 10-150 seconds | No | |
Secondary | Ease of Intubation Visual Analog Scale | Prospective | No |
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