NCT02177240

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

May 29, 2014

Last Update Submit

June 25, 2014

Conditions

Difficult Intubation

Keywords

GlideScope®GlideRite®Flex-it®Difficult intubation

Outcome Measures

Primary Outcomes (1)

  • Intubation time

    Time from start of laryngoscopy to confirmation of EtCO2

    During intubation

Secondary Outcomes (5)

  • Sore throat/Hoarseness

    Day 0 (immediate post-operative)

  • Sore throat/Hoarseness

    Day 1 (24hr post-operative)

  • Verbal Intubation difficulty scale

    15 minutes after intubation

  • Tube manipulation time

    During Intubation

  • Resistance during stylet extraction

    15 minutes after intubation

Study Arms (2)

GRS (GlideRite®)

ACTIVE COMPARATOR

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

Device: GlideScope® intubation with GRS® stylet

FIS (Flex-it® )

ACTIVE COMPARATOR

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

Device: GlideScope® intubation with Flex-it® stylet

Interventions

GlideScope® intubation with Flex-it® styletDEVICE

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

FIS (Flex-it® )
GlideScope® intubation with GRS® styletDEVICE

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

GRS (GlideRite®)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Study Officials

  • John Viet Nguyen, MD

    HMR

    PRINCIPAL INVESTIGATOR

  • Issam Tanoubi, MD

    HMR

    STUDY DIRECTOR

Central Study Contacts

John Viet Nguyen, MD

CONTACT

514-252-3400john.viet.nguyen@umontreal.ca

Issam Tanoubi, MD

CONTACT

514-252-3400

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 27, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

June 27, 2014

Record last verified: 2014-06

Locations

CA(1)