Back to resultsRole 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
About this trial
This is an interventional supportive care trial for Nasal Obstruction focused on measuring Intubation, Airtraq, General anesthesia, Difficult airway
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
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
NCT ID
NCT02510924
First Posted
July 27, 2015
Last Updated
December 29, 2017
Sponsor
University of Lausanne Hospitals
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
background
Learn more about this trial
Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq
We'll reach out to this number within 24 hrs