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A Comparison of the Flex-it® to the GlideRite® Stylet for GlideScope® in Simulated Difficult Intubations.

A Randomized Comparison of the Flex-it® Articulating Stylet to the GlideRite® Rigid Stylet for Orotracheal Intubation Using the GlideScope® in Simulated Difficult Intubations. A Double Blinded Randomized Controlled Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02177240
Enrollment
80
Registered
2014-06-27
Start date
2014-05-31
Completion date
2014-09-30
Last updated
2014-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Intubation

Keywords

GlideScope®, GlideRite®, Flex-it®, Difficult intubation

Brief summary

The purpose of this study is to determine if the Flex-it® Articulating Stylet or the GlideRite® Rigid Stylet is more effective and less traumatic in the context of difficult GlideScope® intubations.

Detailed description

Pre-operatively patient are approached and enrolled according to inclusion and exclusion criteria. Demographic data is then recorded and afterwards the patient is randomized (randomization.com) but is blinded to the group. The patient is outfitted with a Philadelphia® cervical collar and a BIS® monitor before induction of anesthesia. The anesthetist is blinded to the randomization group. Once asleep, the patient is intubated using the GlideScope® with the single-use blade and one of the randomized intubation stylets by an operator. Intubation and tube manipulation times, vital signs and BIS level are recorded via a nurse or video camera. Verbal cues are given for start of laryngoscopy, tube manipulation and confirmation of CO2 which is recorded by the camera microphone. Patient is questioned about hoarseness and sore throat when leaving the post anesthesia care unit according to our local protocol and 24hr after the surgical procedure. The data is then taken from the video and analyzed by a blinded operator.

Interventions

DEVICEGlideScope® intubation with Flex-it® stylet

GlideScope® intubation with Flex-it® stylet of a simulated difficult airway

DEVICEGlideScope® intubation with GRS® stylet

GlideScope® intubation with GRS® stylet of a simulated difficult airway

Sponsors

Maisonneuve-Rosemont Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* ASA status 1-2 * BMI \< 35 * Elective surgery * General Anesthesia

Exclusion criteria

* Difficult intubation * Indication for rapid sequence intubation * Contraindication for cervical collar

Design outcomes

Primary

MeasureTime frameDescription
Intubation timeDuring intubationTime from start of laryngoscopy to confirmation of EtCO2

Secondary

MeasureTime frameDescription
Sore throat/HoarsenessDay 0 (immediate post-operative)Scale of 0 to 3
Verbal Intubation difficulty scale15 minutes after intubationScale of 1 to 10
Tube manipulation timeDuring IntubationTime from start of tube manipulation to confirmation of EtCO2
Resistance during stylet extraction15 minutes after intubationScale of 1 to 5

Countries

Canada

Contacts

Primary ContactJohn Viet Nguyen, MD
john.viet.nguyen@umontreal.ca514-252-3400
Backup ContactIssam Tanoubi, MD
514-252-3400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026