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
About this trial
This is an interventional supportive care trial for Nasal Obstruction
Eligibility Criteria
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
NCT ID
NCT02519647
First Posted
July 27, 2015
Last Updated
February 27, 2020
Sponsor
University of Lausanne Hospitals
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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