NCT02519647

Brief Summary

Intubation with an unchanneled videolaryngoscope mandates the use of a stylet. The Gliderite is a stylet specially designed for videolaryngoscopes. The investigators aim to compare the efficacy of a new designed bougie for intubation in patients with simulated difficult airways.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2016

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

July 27, 2015

Last Update Submit

February 27, 2020

Conditions

Nasal ObstructionLumbar Stenosis, Familial

Outcome Measures

Primary Outcomes (1)

  • Time necessary to intubate

    Time needed to pass tracheal tube through vocal cords

    50 seconds

Secondary Outcomes (3)

  • Standardized questionnaire assessing injury after intubation

    50 seconds

  • Standardized questionnaire assessing ease of use of the intubation

    50 seconds

  • Subjective ease of use of the intubation assessed by questionnaire

    50 seconds

Study Arms (2)

tracheal intubation with Gliderite

ACTIVE COMPARATOR

Gliderite will be used for intubation

Device: Tracheal intubation with Gliderite

Tracheal intubation with S-Guide

EXPERIMENTAL

S-Guide will be used for intubation

Device: Tracheal intubation with S-guide

Interventions

Tracheal intubation with GlideriteDEVICE

Tracheal intubation with Gliderite

tracheal intubation with Gliderite
Tracheal intubation with S-guideDEVICE

Tracheal intubation with S-guide

Tracheal intubation with S-Guide

Eligibility Criteria

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

You may qualify if:

  • Surgery necessitating general anesthesia and orotracheal intubation

You may not qualify if:

  • History or criteria of difficult intubation
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of Anesthesiology, University of Lausanne CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Nasal ObstructionLumbar Stenosis, Familial

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • patrick Schoettker, MD, PD

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 11, 2015

Study Start

August 1, 2015

Primary Completion

May 2, 2016

Study Completion

June 2, 2016

Last Updated

March 2, 2020

Record last verified: 2020-02

Locations

CH(1)