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Evaluation of Video Laryngoscopes in Difficult Airway (SWIVIT I)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01692535
First Posted: September 25, 2012
Last Update Posted: June 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centre Hospitalier Universitaire Vaudois
University Hospital, Geneva
Information provided by (Responsible Party):
Lorenz Theiler, University Hospital Inselspital, Berne
  Purpose

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.


Condition Intervention
Intubation; Difficult Procedure: Intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Multicenter Study Evaluating Video Laryngoscopes: The Swiss Video-Intubation Trial (SWIVIT I)

Further study details as provided by Lorenz Theiler, University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • First attempt intubation success rate [ Time Frame: within 180 seconds ]

Secondary Outcome Measures:
  • side effects [ Time Frame: 1h and 1 day after surgery ]
    sore throat, bleeding, dental injuries


Enrollment: 720
Study Start Date: January 2013
Study Completion Date: June 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692535


Locations
Switzerland
Hopitaux Universitaires de Geneve HUG
Geneva, GE, Switzerland
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, VD, Switzerland
Bern University Hospital and University of Bern
Bern, Switzerland, 3011
Sponsors and Collaborators
University Hospital Inselspital, Berne
Centre Hospitalier Universitaire Vaudois
University Hospital, Geneva
Investigators
Study Chair: Robert Greif, MD MME FERC University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland