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

Comparison of Intubation Conditions Between the Gliderite and the S-Guide in Patients With Simulated Difficult Airways

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.

Study Overview

• Status: Completed
• Conditions: Nasal Obstruction; Lumbar Stenosis, Familial
• Intervention / Treatment: Device: Tracheal intubation with Gliderite; Device: Tracheal intubation with S-guide

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1011
      • Dpt of Anesthesiology, University of Lausanne CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Surgery necessitating general anesthesia and orotracheal intubation

Exclusion Criteria:

• History or criteria of difficult intubation
• Patient refusal

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: tracheal intubation with Gliderite; Gliderite will be used for intubation	Device: Tracheal intubation with Gliderite; Tracheal intubation with Gliderite
EXPERIMENTAL: Tracheal intubation with S-Guide; S-Guide will be used for intubation	Device: Tracheal intubation with S-guide; Tracheal intubation with S-guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time necessary to intubate	Time needed to pass tracheal tube through vocal cords	50 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized questionnaire assessing injury after intubation	Assessment of discomfort after procedure	50 seconds
Standardized questionnaire assessing ease of use of the intubation	assessment by doctor of ease of intubation	50 seconds
Subjective ease of use of the intubation assessed by questionnaire	assessment by doctor of ease of intubation	50 seconds

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): May 2, 2016
• Study Completion (ACTUAL): June 2, 2016

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (ESTIMATE): August 11, 2015

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: 267/15 (Other Identifier: Hospital Civil de Guadalajara Etical of Investigative Committee)