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GlideRite® Rigid Stylet Versus Parker Flex-It Stylet

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ClinicalTrials.gov Identifier: NCT02439606
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Ashraf Arafat Abdelhalim, King Saud University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Device: Glide Rite Rigid Stylet group Device: Parker Flex-It directional stylet group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: GlideRite® Rigid Stylet Versus Parker Flex-It Stylet for Orotracheal Intubation by GlideScope
Study Start Date : May 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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.




Primary Outcome Measures :
  1. total intubation time [ Time Frame: measured during intubation ( up to 120 seconds) ]
    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.


Secondary Outcome Measures :
  1. number of intubation attempts before successful intubation [ Time Frame: 5minutes ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439606


Sponsors and Collaborators
King Saud University
Investigators
Principal Investigator: Ashraf Abdelhalim, MD King Saud University

Responsible Party: Ashraf Arafat Abdelhalim, Assistant professor, Department of Anesthesia, King Saud University
ClinicalTrials.gov Identifier: NCT02439606     History of Changes
Other Study ID Numbers: E-14-1074
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Ashraf Arafat Abdelhalim, King Saud University:
GlideRite
Stylet
Parker
orotracheal
intubation
GlideScope