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

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Difficult Intubation Device: Airtraq, blade without channel for tracheal tube intubation Device: KingVision , blade without channel for tracheal tube intubation Device: A.P. Advance, blade without channel for tracheal tube intubation Device: Macintosh Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Phase 2 Study of Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
Study Start Date : February 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. first attempt intubation success rate [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. side effects [ Time Frame: 1h and 1day after intubation ]
    sore throat, bleeding, dental injuries


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088801


Locations
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Switzerland
Bern University Hospital and University of Bern
Bern, Switzerland, 3011
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: Robert Greif, MD MME FERC University Hospital Inselspital, Berne
More Information
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Responsible Party: Lorenz Theiler, Principle investigator, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02088801    
Other Study ID Numbers: 106/12_2
SWIVIT II
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015
Keywords provided by Lorenz Theiler, University Hospital Inselspital, Berne:
Intubation; Difficult
Additional relevant MeSH terms:
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Pyrithione zinc
Keratolytic Agents
Dermatologic Agents