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

Primary Purpose

Nasal Obstruction, Arthrosis

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Tracheal intubation
Sponsored by
University of Lausanne Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nasal Obstruction focused on measuring Intubation, Airtraq, General anesthesia, Difficult airway

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dpt of Anesthesiology, University of Lausanne CHUV

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Tracheal intubation with Airtraq sp

Tracheal intubation with Airtraq Mobile

Arm Description

Tracheal intubation with Airtraq sp.

Tracheal intubation with Airtraq Mobile

Outcomes

Primary Outcome Measures

Success
Success of intubation within time frame

Secondary Outcome Measures

Number of attempts
Success of intubation within time frame
Number of injuries
Injuries within time frame

Full Information

First Posted
July 27, 2015
Last Updated
December 29, 2017
Sponsor
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT02510924
Brief Title
Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq
Acronym
AirtraqMob
Official Title
Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq in Adults With a Simulated Difficult Airway With a Cervical-spine Collar
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
November 5, 2017 (Actual)
Study Completion Date
November 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Arthrosis
Keywords
Intubation, Airtraq, General anesthesia, Difficult airway

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tracheal intubation with Airtraq sp
Arm Type
Active Comparator
Arm Description
Tracheal intubation with Airtraq sp.
Arm Title
Tracheal intubation with Airtraq Mobile
Arm Type
Experimental
Arm Description
Tracheal intubation with Airtraq Mobile
Intervention Type
Device
Intervention Name(s)
Tracheal intubation
Intervention Description
tracheal intubation with Airtraq sp vs Airtraq mobile
Primary Outcome Measure Information:
Title
Success
Description
Success of intubation within time frame
Time Frame
180 seconds
Secondary Outcome Measure Information:
Title
Number of attempts
Description
Success of intubation within time frame
Time Frame
180 seconds
Title
Number of injuries
Description
Injuries within time frame
Time Frame
180 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Schoettker, MD, PD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt of Anesthesiology, University of Lausanne CHUV
City
Lausanne
State/Province
VD
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26161393
Citation
Schoettker P, Corniche J. The AirView Study: Comparison of Intubation Conditions and Ease between the Airtraq-AirView and the King Vision. Biomed Res Int. 2015;2015:284142. doi: 10.1155/2015/284142. Epub 2015 Jun 16.
Results Reference
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Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq

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