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
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
-
-
-
Bern, Switzerland, 3011
- Bern University Hospital and University of Bern
-
-
GE
-
Geneva, GE, Switzerland
- Hôpitaux Universitaires de Genève HUG
-
-
VD
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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
|
Intubation with one of the six videolaryngoscopes
|
|
Experimental: Airtraq
intubation
|
Intubation with one of the six videolaryngoscopes
|
|
Experimental: McGrath MAC
intubation
|
Intubation with one of the six videolaryngoscopes
|
|
Experimental: King Vision
intubation
|
Intubation with one of the six videolaryngoscopes
|
|
Experimental: A.P. Advance
intubation
|
Intubation with one of the six videolaryngoscopes
|
|
Experimental: C-MAC
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.
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
- Kleine-Brueggeney M, Greif R, Schoettker P, Savoldelli GL, Nabecker S, Theiler LG. Evaluation of six videolaryngoscopes in 720 patients with a simulated difficult airway: a multicentre randomized controlled trial. Br J Anaesth. 2016 May;116(5):670-9. doi: 10.1093/bja/aew058.
- Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94.
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.