Evaluation of Videolaryngoscopes in Difficult Airway (SWI... | NCT02088801

Studies
Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)

NCT02088801

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Completed

Last Update Posted

Jun 11, 2015Estimated

Enrollment

480Actual

Phase

Not Applicable

Conditions

Difficult Intubation

Interventions

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

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
SWIVIT II

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Mar 11, 2014

First Submission Date that Met QC Criteria

Mar 14, 2014

First Posted Date

Mar 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2015

Last Update Posted Date

Jun 11, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lorenz Theiler, Principle investigator, Insel Gruppe AG, University Hospital BernPrincipal Investigator

Lead Sponsor

Insel Gruppe AG, University Hospital BernOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

480Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Airtraq, blade without channel for tracheal tube	Experimental	intubation	Device: Airtraq, blade without channel for tracheal tube intubation
KingVision , blade without channel for tracheal tube	Experimental	intubation	Device: KingVision , blade without channel for tracheal tube intubation
A.P. Advance, blade without channel for tracheal tube	Experimental	intubation	Device: A.P. Advance, blade without channel for tracheal tube intubation
Macintosh	Experimental	intubation	Device: Macintosh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Airtraq, blade without channel for tracheal tube intubation	Device	Intubation	Airtraq, blade without channel for tracheal tube

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
first attempt intubation success rate		intraoperative

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Greif, MD MME FERC	Insel Gruppe AG, University Hospital Bern	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bern University Hospital and University of Bern		Bern	Canton of Bern	3011	Switzerland

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.