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NCT01692535 Clinical Trial

Evaluation of Video Laryngoscopes in Difficult Airway

Intubation; Difficult Clinical Trial

— SWIVIT I  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01692535
Other study ID # 106/12
Secondary ID
Status Completed
Phase N/A
First received September 17, 2012
Last updated June 10, 2015
Start date January 2013
Est. completion date June 2015

Study information
Verified date June 2015
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 720
Est. completion date June 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Procedure:
• Intubation
Intubation with one of the six videolaryngoscopes

Locations
Country Name City State
Switzerland Bern University Hospital and University of Bern Bern
Switzerland Hopitaux Universitaires de Geneve HUG Geneva GE
Switzerland Centre Hospitalier Universitaire Vaudois CHUV Lausanne VD

Sponsors (3)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne Centre Hospitalier Universitaire Vaudois, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary First attempt intubation success rate within 180 seconds No
Secondary side effects sore throat, bleeding, dental injuries 1h and 1 day after surgery Yes
See also
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Completed NCT02198742 - A Comparison Between Two Video Laryngoscopes,in Successfully Intubating Pediatric Mannequins w/wo Difficult Airways Phase 1