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Comparison of Intubation Conditions Between the Gliderite and the S-Guide (S-Guide)

Primary Purpose

Nasal Obstruction, Lumbar Stenosis, Familial

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Tracheal intubation with Gliderite
Tracheal intubation with S-guide
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nasal Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Surgery necessitating general anesthesia and orotracheal intubation

Exclusion Criteria:

  • History or criteria of difficult intubation
  • Patient refusal

Sites / Locations

  • Dpt of Anesthesiology, University of Lausanne CHUV

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

tracheal intubation with Gliderite

Tracheal intubation with S-Guide

Arm Description

Gliderite will be used for intubation

S-Guide will be used for intubation

Outcomes

Primary Outcome Measures

Time necessary to intubate
Time needed to pass tracheal tube through vocal cords

Secondary Outcome Measures

Standardized questionnaire assessing injury after intubation
Assessment of discomfort after procedure
Standardized questionnaire assessing ease of use of the intubation
assessment by doctor of ease of intubation
Subjective ease of use of the intubation assessed by questionnaire
assessment by doctor of ease of intubation

Full Information

First Posted
July 27, 2015
Last Updated
February 27, 2020
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02519647
Brief Title
Comparison of Intubation Conditions Between the Gliderite and the S-Guide
Acronym
S-Guide
Official Title
Comparison of Intubation Conditions Between the Gliderite and the S-Guide in Patients With Simulated Difficult Airways
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
May 2, 2016 (Actual)
Study Completion Date
June 2, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. The primary endpoint will be time necessary for intubation, secondary endpoints will be injuries, ease of use and subjective assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Lumbar Stenosis, Familial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tracheal intubation with Gliderite
Arm Type
Active Comparator
Arm Description
Gliderite will be used for intubation
Arm Title
Tracheal intubation with S-Guide
Arm Type
Experimental
Arm Description
S-Guide will be used for intubation
Intervention Type
Device
Intervention Name(s)
Tracheal intubation with Gliderite
Intervention Description
Tracheal intubation with Gliderite
Intervention Type
Device
Intervention Name(s)
Tracheal intubation with S-guide
Intervention Description
Tracheal intubation with S-guide
Primary Outcome Measure Information:
Title
Time necessary to intubate
Description
Time needed to pass tracheal tube through vocal cords
Time Frame
50 seconds
Secondary Outcome Measure Information:
Title
Standardized questionnaire assessing injury after intubation
Description
Assessment of discomfort after procedure
Time Frame
50 seconds
Title
Standardized questionnaire assessing ease of use of the intubation
Description
assessment by doctor of ease of intubation
Time Frame
50 seconds
Title
Subjective ease of use of the intubation assessed by questionnaire
Description
assessment by doctor of ease of intubation
Time Frame
50 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Surgery necessitating general anesthesia and orotracheal intubation Exclusion Criteria: History or criteria of difficult intubation Patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
patrick Schoettker, MD, PD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt of Anesthesiology, University of Lausanne CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Comparison of Intubation Conditions Between the Gliderite and the S-Guide

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