Role of Airtraq Mobile to Improve Intubation Conditions W... | NCT02510924

Studies
Role of Airtraq Mobile to Improve Intubation Conditions With Airtraq

NCT02510924

Sponsor

University of Lausanne Hospitals

Status

Completed

Last Update Posted

Jan 2, 2018Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Nasal Obstruction
Arthrosis

Interventions

Tracheal intubation

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015Actual

Primary Completion Date

Nov 5, 2017Actual

Completion Date

Nov 5, 2017Actual

First Submitted Date

Jul 27, 2015

First Submission Date that Met QC Criteria

Jul 28, 2015

First Posted Date

Jul 29, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2017

Last Update Posted Date

Jan 2, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick Schoettker,MD PD, MD, PD, University of Lausanne HospitalsPrincipal Investigator

Lead Sponsor

University of Lausanne HospitalsOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tracheal intubation with Airtraq sp	Active Comparator	Tracheal intubation with Airtraq sp.	Device: Tracheal intubation
Tracheal intubation with Airtraq Mobile	Experimental	Tracheal intubation with Airtraq Mobile	Device: Tracheal intubation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tracheal intubation	Device	tracheal intubation with Airtraq sp vs Airtraq mobile	Tracheal intubation with Airtraq Mobile Tracheal intubation with Airtraq sp

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Schoettker, MD, PD	University of Lausanne Hospitals	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dpt of Anesthesiology, University of Lausanne CHUV		Lausanne	Canton of Vaud	1011	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26161393	Background	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.

ID	Term
D015508	Nasal Obstruction
D010003	Osteoarthritis

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D000402	Airway Obstruction
D012131	Respiratory Insufficiency

ID	Term
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation
D008919	Investigative Techniques