GlideRite® Rigid Stylet Versus Parker Flex-It Stylet

GlideRite® Rigid Stylet Versus Parker Flex-It Stylet for Orotracheal Intubation by GlideScope

This prospective randomized trial evaluated Parker Flex-It stylet as an alternative to manufacturer, s GlideRite® Rigid Stylet to aid intubation with the GlideScope in patients undergoing elective non-cardiac surgery that required general anesthesia with orotracheal intubation.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Device: Glide Rite Rigid Stylet group; Device: Parker Flex-It directional stylet group

Detailed Description

The GlideScope® Ranger (GVL; Verathon Medical Inc., Bothell, WA, USA) is a novel portable, reusable video laryngoscope that has provided superior laryngeal visualization to facilitate tracheal intubation especially in the management of difficult airways; it provides indirect visualization of the glottis with a pronounced angle of 60° in the blade. It has separate monitor connected to the handle via a cable. The tip of the blade is equipped with high-resolution digital video camera, an LED light and an antifogging system.

Unlike the Macintosh laryngoscope, an indirect laryngoscope such as the GlideScope device provides a view of the glottis without the need to align the oral pharyngeal and laryngeal axes facilitating an excellent glottic visualization. However, insertion and advancement of the endotracheal tube (ETT) may be more difficult to pass through the vocal cords than direct laryngoscopy, and trauma is possible.

The GlideScope have shown to function better when used in conjunction with use of a stylet to guide insertion of endotracheal tube. The GlideRite Rigid Stylet (GRS) is a reusable rigid steel stylet, specifically designed by the manufacturer to resemble the distal part of the GVL blade for clear view of the airway, enabling quick intubation , its curvature approaches 90° with a radius of curvature of approximately 6 cm.

Various investigators have recommended different curvatures of the ETT/stylet to optimally direct it into the trachea, including matching the blade's 60° angle, configuring the ETT with a 90° bend, or using a J-shaped ETT. Other potential strategies may include the use of a flexible stylet that allows active modification of the tip of the tracheal tube during use.

The Parker Flex-It Directional Stylet (FIS, Parker Medical, Highlands Ranch, CO) is a 2-piece plastic stylet, can be used for oral intubation, and allows continuous adjustment of the tube curvature during an intubation to enable the tube to follow the curvature of the airway. We hypothesized that the use of Parker Flex-It stylet to guide ETT might offer some benefit over the GRS.

Therefore, the purpose of this study was to determine the optimal stylet-tracheal tube strategy for use with the GlideScope® laryngoscope. We compared efficacy of the two intubating aids including GlideRite® Rigid Stylet versus Parker Flex-It stylet for orotracheal intubation in terms of the total intubation time (primary outcome), ease of intubation, the number of intubation attempts , the number of optimization man oeuvres and possible trauma (secondary outcomes) when used by experienced GlideScope operators.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status I&II,
• body mass index (BMI) < 35
• elective non-cardiac surgery
• general anaesthesia with orotracheal intubation

Exclusion Criteria:

• Anticipated difficult airway,
• need for rapid sequence induction,
• ASA physical status III-V,
• increase risk of gastric aspiration such as gastro- oesophageal reflux,
• pregnancy,
• patients who had no teeth, loose teeth or oral trauma, known pathology or previous surgery to the mouth, pharynx, larynx or cervical spine and any reason why the GlideScope is not, or could not be used.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glide Rite Rigid Stylet group; Intubation with the GlideScope® video-laryngoscope and styletted the tracheal tube using manufacturer's GlideRite Rigid Stylet (GRS) (GVL - ST1; Verathon Medical Inc., Bothell, WA, USA). Time till successful intubation of the patient is calculated.	Device: Glide Rite Rigid Stylet group; Intubation with the GlideScope® video-laryngoscope and styletted the tracheal tube using manufacturer's GlideRite Rigid Stylet (GRS) (GVL - ST1; Verathon Medical Inc., Bothell, WA, USA). Time till successful intubation of the patient is calculated.
Experimental: Parker-Flex-It Directional Stylet group; Intubated with the GlideScope® video-laryngoscope and styletted the tracheal tube using Parker-Flex-It Directional Stylet (Parker Medical, Colorado, USA) (Flexi-Stylet). Time till successful intubation of the patient is calculated.	Device: Parker Flex-It directional stylet group; Intubated with the GlideScope® video-laryngoscope and styletted the tracheal tube using Parker-Flex-It directional Stylet (Parker Medical, Colorado, USA) (Flexi-Stylet). Time till successful intubation of the patient is calculated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total intubation time	the time from insertion of the blade of the GlideScope into the oral airway to the appearance of end-tidal carbon dioxide (ETCO2) curve of at least 30 mmHg on the anesthesia monitor after insertion of the tracheal tube.	measured during intubation ( up to 120 seconds)

Secondary Outcome Measures

Outcome Measure	Time Frame
number of intubation attempts before successful intubation	5minutes

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Principal Investigator: Ashraf Abdelhalim, MD, King Saud University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 6, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: intubation; GlideRite; Stylet; Parker; orotracheal; GlideScope
• Other Study ID Numbers: E-14-1074