Evaluation of Video Laryngoscopes in Difficult Airway (SWIVIT I)

June 10, 2015 updated by: Lorenz Theiler, University Hospital Inselspital, Berne

Multicenter Study Evaluating Video Laryngoscopes: The Swiss Video-Intubation Trial (SWIVIT I)

In this multicenter study the investigators are going to evaluate the use of six different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these six videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As gold standard, a standard Macintosh blade is being used.

The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3011
        • Bern University Hospital and University of Bern
    • GE
      • Geneva, GE, Switzerland
        • Hôpitaux Universitaires de Genève HUG
    • VD
      • Lausanne, VD, Switzerland
        • Centre Hospitalier Universitaire Vaudois CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • elective surgery with general anesthesia requiring intubation
  • >18years old
  • ASA I-III

Exclusion Criteria:

  • known or presumed difficult airway
  • risk of pulmonary aspiration
  • refusing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GlideScope
intubation
Procedure: Intubation
Intubation with one of the six videolaryngoscopes
Experimental: Airtraq
intubation
Procedure: Intubation
Intubation with one of the six videolaryngoscopes
Experimental: McGrath MAC
intubation
Procedure: Intubation
Intubation with one of the six videolaryngoscopes
Experimental: King Vision
intubation
Procedure: Intubation
Intubation with one of the six videolaryngoscopes
Experimental: A.P. Advance
intubation
Procedure: Intubation
Intubation with one of the six videolaryngoscopes
Experimental: C-MAC
intubation
Procedure: Intubation
Intubation with one of the six videolaryngoscopes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First attempt intubation success rate
Time Frame: within 180 seconds
within 180 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects
Time Frame: 1h and 1 day after surgery
sore throat, bleeding, dental injuries
1h and 1 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

University Hospital, Geneva
Centre Hospitalier Universitaire Vaudois

Investigators

  • Study Chair: Robert Greif, MD MME FERC, University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 25, 2012

Study Record Updates

Last Update Posted (Estimate)

June 11, 2015

Last Update Submitted That Met QC Criteria

June 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 106/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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