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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02177240
Other study ID # Cér 14013
Secondary ID
Status Recruiting
Phase N/A
First received May 29, 2014
Last updated June 25, 2014
Start date May 2014
Est. completion date September 2014

Study information

Verified date June 2014
Source Maisonneuve-Rosemont Hospital
Contact John Viet Nguyen, MD
Phone 514-252-3400
Email john.viet.nguyen@umontreal.ca
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Hôpital Maisonneuve-Rosemont Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intubation time Time from start of laryngoscopy to confirmation of EtCO2 During intubation No
Secondary Sore throat/Hoarseness Scale of 0 to 3 Day 0 (immediate post-operative) Yes
Secondary Sore throat/Hoarseness Scale of 0 to 3 Day 1 (24hr post-operative) Yes
Secondary Verbal Intubation difficulty scale Scale of 1 to 10 15 minutes after intubation No
Secondary Tube manipulation time Time from start of tube manipulation to confirmation of EtCO2 During Intubation No
Secondary Resistance during stylet extraction Scale of 1 to 5 15 minutes after intubation No
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