NCT01692535

Brief Summary

In this multicenter study the investigators are going to evaluate the use of six different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these six videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As gold standard, a standard Macintosh blade is being used. The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720 patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 11, 2015

Status Verified

June 1, 2015

Enrollment Period

2.3 years

First QC Date

September 17, 2012

Last Update Submit

June 10, 2015

Conditions

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

  • First attempt intubation success rate

    within 180 seconds

Secondary Outcomes (1)

  • side effects

    1h and 1 day after surgery

Study Arms (6)

GlideScope

EXPERIMENTAL

intubation

Procedure: Intubation

Airtraq

EXPERIMENTAL

intubation

Procedure: Intubation

McGrath MAC

EXPERIMENTAL

intubation

Procedure: Intubation

King Vision

EXPERIMENTAL

intubation

Procedure: Intubation

A.P. Advance

EXPERIMENTAL

intubation

Procedure: Intubation

C-MAC

EXPERIMENTAL

intubation

Procedure: Intubation

Interventions

IntubationPROCEDURE

Intubation with one of the six videolaryngoscopes

A.P. AdvanceAirtraqC-MACGlideScopeKing VisionMcGrath MAC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective surgery with general anesthesia requiring intubation
  • \>18years old
  • ASA I-III

You may not qualify if:

  • known or presumed difficult airway
  • risk of pulmonary aspiration
  • refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bern University Hospital and University of Bern

Bern, Canton of Bern, 3011, Switzerland

Location

Hopitaux Universitaires de Geneve HUG

Geneva, Canton of Geneva, Switzerland

Location

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, Canton of Vaud, Switzerland

Location

Related Publications (2)

  • Kleine-Brueggeney M, Greif R, Schoettker P, Savoldelli GL, Nabecker S, Theiler LG. Evaluation of six videolaryngoscopes in 720 patients with a simulated difficult airway: a multicentre randomized controlled trial. Br J Anaesth. 2016 May;116(5):670-9. doi: 10.1093/bja/aew058.

    PMID: 27106971DERIVED

  • Theiler L, Hermann K, Schoettker P, Savoldelli G, Urwyler N, Kleine-Brueggeney M, Arheart KL, Greif R. SWIVIT--Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland. Trials. 2013 Apr 4;14:94. doi: 10.1186/1745-6215-14-94.

    PMID: 23556410DERIVED

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Robert Greif, MD MME FERC

    University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 25, 2012

Study Start

January 1, 2013

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

CH(3)