Evaluation of Video Laryngoscopes in Difficult Airway (SWIVIT I)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital Inselspital, Berne
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Vaudois
University Hospital, Geneva
Information provided by (Responsible Party):
Lorenz Theiler, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01692535
First received: September 17, 2012
Last updated: March 11, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Multicenter Study Evaluating Video Laryngoscopes: The Swiss Video-Intubation Trial (SWIVIT I)

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

Primary Outcome Measures:
  • First attempt intubation success rate [ Time Frame: within 180 seconds ] [ Designated as safety issue: No ]

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


Estimated Enrollment: 720
Study Start Date: January 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692535

Contacts
Contact: Lorenz G Theiler, MD +41 (31) 632 2111 ext 7837 lorenz.theiler@insel.ch
Contact: Robert Greif, MD MME FERC +41 (31) 632 2111 ext 7848 robert.greif@insel.ch

Locations
Switzerland
Hopitaux Universitaires de Geneve HUG Recruiting
Geneva, GE, Switzerland
Contact: Georges Savoldelli, MD       georges.savoldelli@hcuge.ch   
Principal Investigator: Georges Savoldelli, MD         
Centre Hospitalier Universitaire Vaudois CHUV Recruiting
Lausanne, VD, Switzerland
Contact: Patrick Schoettker, MD       patrick.schoettker@chuv.insel   
Principal Investigator: Patrick Schoettker, MD         
Bern University Hospital and University of Bern Recruiting
Bern, Switzerland, 3011
Contact: Lorenz Theiler, MD    +41 (31) 632 2111 ext 7837    lorenz.theiler@insel.ch   
Principal Investigator: Lorenz G Theiler, MD         
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
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lorenz Theiler, Principal Investigator, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01692535     History of Changes
Other Study ID Numbers: 106/12
Study First Received: September 17, 2012
Last Updated: March 11, 2014
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on July 22, 2014