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Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)

NCT ID: NCT02088801

Last Updated: 2015-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Difficult Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Airtraq, blade without channel for tracheal tube

intubation

Group Type EXPERIMENTAL

Airtraq, blade without channel for tracheal tube intubation

Intervention Type DEVICE

Intubation

KingVision , blade without channel for tracheal tube

intubation

Group Type EXPERIMENTAL

KingVision , blade without channel for tracheal tube intubation

Intervention Type DEVICE

A.P. Advance, blade without channel for tracheal tube

intubation

Group Type EXPERIMENTAL

A.P. Advance, blade without channel for tracheal tube intubation

Intervention Type DEVICE

Macintosh

intubation

Group Type EXPERIMENTAL

Macintosh

Intervention Type DEVICE

Interventions

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Airtraq, blade without channel for tracheal tube intubation

Intubation

Intervention Type DEVICE

KingVision , blade without channel for tracheal tube intubation

Intervention Type DEVICE

A.P. Advance, blade without channel for tracheal tube intubation

Intervention Type DEVICE

Macintosh

Intervention Type DEVICE

Other Intervention Names

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Airtraq A.P. Advance KingVision Macintosh

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Lorenz Theiler

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Greif, MD MME FERC

Role: STUDY_CHAIR

Insel Gruppe AG, University Hospital Bern

Locations

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Bern University Hospital and University of Bern

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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SWIVIT II

Identifier Type: -

Identifier Source: secondary_id

106/12_2

Identifier Type: -

Identifier Source: org_study_id

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