Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq (AirtraqMob)

December 29, 2017 updated by: Patrick Schoettker,MD PD, University of Lausanne Hospitals

Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq in Adults With a Simulated Difficult Airway With a Cervical-spine Collar

Airtraq sp has been proven effective for intubating patients presenting with difficult airway.

The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.

By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.

The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Airtraq sp has been proven effective for intubating patients presenting with difficult airway.

The Airtraq sp allows visualisation of the tracheal inlet only for the intubator.

By adding a smartphone with a dedicated app (Airtraq Mobile) to the Airtraq sp, the visualisation of the tracheal inlet is possible for all the airway providers.

The investigators aim to demonstrate that the addition of the Airtraq Mobile app improves success rate of intubation (primary endpoint), as well as confort of the airway provider, shortens time for intubation and reduces injury to the patients while their neck is imobilized by a cervical collar, creating a simulated difficult airway.

Patients will be included if they necessitate an elective general anesthesia and orotracheal intubation.

Exclusion criteria are related to difficult airway, ASA IV and patient refusal.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • VD
      • Lausanne, VD, Switzerland, 1011
        • Dpt of Anesthesiology, University of Lausanne CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesia classification 1-3, elective surgey necessitating general anesthesia and intubation, patient consent

Exclusion Criteria:

  • American Society of Anesthesia classification 4, patient refusal, history of difficult airway

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tracheal intubation with Airtraq sp
Tracheal intubation with Airtraq sp.
Device: Tracheal intubation
tracheal intubation with Airtraq sp vs Airtraq mobile
Experimental: Tracheal intubation with Airtraq Mobile
Device: Tracheal intubation
tracheal intubation with Airtraq sp vs Airtraq mobile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success
Time Frame: 180 seconds
Success of intubation within time frame
180 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts
Time Frame: 180 seconds
Success of intubation within time frame
180 seconds
Number of injuries
Time Frame: 180 seconds
Injuries within time frame
180 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

November 5, 2017

Study Completion (Actual)

November 5, 2017

Study Registration Dates

First Submitted

July 27, 2015

First Submitted That Met QC Criteria

July 28, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Actual)

January 2, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 409/14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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