NCT02088801

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day 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

1.3 years

First QC Date

March 11, 2014

Last Update Submit

June 10, 2015

Conditions

Difficult Intubation

Keywords

Intubation; Difficult

Outcome Measures

Primary Outcomes (1)

  • first attempt intubation success rate

    intraoperative

Secondary Outcomes (1)

  • side effects

    1h and 1day after intubation

Study Arms (4)

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

Airtraq, blade without channel for tracheal tube intubationDEVICE

Intubation

Also known as: Airtraq, A.P. Advance, KingVision, Macintosh
Airtraq, blade without channel for tracheal tube
KingVision , blade without channel for tracheal tube intubationDEVICE
KingVision , blade without channel for tracheal tube
A.P. Advance, blade without channel for tracheal tube intubationDEVICE
A.P. Advance, blade without channel for tracheal tube
MacintoshDEVICE
Macintosh

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective surgery with general anesthesia requiring intubation
  • \>18 years 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 (1)

Bern University Hospital and University of Bern

Bern, Canton of Bern, 3011, Switzerland

Location

Study Officials

  • Robert Greif, MD MME FERC

    Insel Gruppe AG, University Hospital Bern

    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
Principle investigator

Study Record Dates

First Submitted

March 11, 2014

First Posted

March 17, 2014

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 11, 2015

Record last verified: 2015-06

Locations

CH(1)