Comparison of Flex-It Stylet to Malleable Stylet for GlideScope Intubation: A Randomized Controlled Trial

NCT00771628 | Completed

• 2 other identifiers: R-08-11113949
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation

Keywords

Intubation, Flex-It, stylet, GlideScope

Outcome Measures

Primary Outcomes (1)

• Time to Intubation

  Prospective 10-150 seconds

Secondary Outcomes (1)

• Ease of Intubation Visual Analog Scale

  Prospective

Study Arms (2)

Flex-It Stylet

EXPERIMENTAL

Patients will be intubated using the GlideScope with an ETT fitted with a Flex-It stylet.

Device: Flex-It Stylet

2 Malleable

ACTIVE COMPARATOR

Device: Standard malleable stylet

Interventions

Flex-It Stylet DEVICE

Patients will be intubated using the GlideScope with an ETT fitted with a Flex-It stylet.

Flex-It Stylet

Standard malleable stylet DEVICE

Patients will be intubated using the GlideScope with an ETT fitted with a standard malleable stylet.

2 Malleable

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• London Health Sciences Centre: collaborator
• Unity Health Toronto: collaborator

Study Sites (1)

London Health Sciences Center

London, Ontario, Canada

Location

Related Publications (1)

• Turkstra TP, Jones PM, Ower KM, Gros ML. The Flex-It stylet is less effective than a malleable stylet for orotracheal intubation using the GlideScope. Anesth Analg. 2009 Dec;109(6):1856-9. doi: 10.1213/ANE.0b013e3181bc116a.

  PMID: 19923515 DERIVED

Study Officials

• Timothy P Turkstra, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 13, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 14, 2009

Record last verified: 2009-07

Locations

CA (1)