Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII) (SWIVITII)

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

Phase 2 Study of Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)

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

The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

480

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

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective surgery with general anesthesia requiring intubation
  • >18 years 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: Airtraq, blade without channel for tracheal tube
intubation
Device: Airtraq, blade without channel for tracheal tube intubation
Intubation
Other Names:
  • Airtraq
  • A.P. Advance
  • KingVision
  • Macintosh
Experimental: KingVision , blade without channel for tracheal tube
intubation
Device: KingVision , blade without channel for tracheal tube intubation
Experimental: A.P. Advance, blade without channel for tracheal tube
intubation
Device: A.P. Advance, blade without channel for tracheal tube intubation
Experimental: Macintosh
intubation
Device: Macintosh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
first attempt intubation success rate
Time Frame: intraoperative
intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Study Chair: Robert Greif, MD MME FERC, University Hospital Inselspital, Berne

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

February 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 17, 2014

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106/12_2
  • SWIVIT II

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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