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

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.
 
ClinicalTrials.gov Identifier: NCT02088801
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
Lorenz Theiler, University Hospital Inselspital, Berne

Tracking Information
First Submitted Date  ICMJE March 11, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date June 11, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
first attempt intubation success rate [ Time Frame: intraoperative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2014)
side effects [ Time Frame: 1h and 1day after intubation ]
sore throat, bleeding, dental injuries
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
Official Title  ICMJE Phase 2 Study of Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Condition  ICMJE Difficult Intubation
Intervention  ICMJE
  • Device: Airtraq, blade without channel for tracheal tube intubation
    Intubation
    Other Names:
    • Airtraq
    • A.P. Advance
    • KingVision
    • Macintosh
  • Device: KingVision , blade without channel for tracheal tube intubation
  • Device: A.P. Advance, blade without channel for tracheal tube intubation
  • Device: Macintosh
Study Arms  ICMJE
  • Experimental: Airtraq, blade without channel for tracheal tube
    intubation
    Intervention: Device: Airtraq, blade without channel for tracheal tube intubation
  • Experimental: KingVision , blade without channel for tracheal tube
    intubation
    Intervention: Device: KingVision , blade without channel for tracheal tube intubation
  • Experimental: A.P. Advance, blade without channel for tracheal tube
    intubation
    Intervention: Device: A.P. Advance, blade without channel for tracheal tube intubation
  • Experimental: Macintosh
    intubation
    Intervention: Device: Macintosh
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2014)
480
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088801
Other Study ID Numbers  ICMJE 106/12_2
SWIVIT II
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lorenz Theiler, University Hospital Inselspital, Berne
Study Sponsor  ICMJE University Hospital Inselspital, Berne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert Greif, MD MME FERC University Hospital Inselspital, Berne
PRS Account University Hospital Inselspital, Berne
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP