NCT02510924

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

July 27, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2017

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

2.3 years

First QC Date

July 27, 2015

Last Update Submit

December 29, 2017

Conditions

Nasal ObstructionArthrosis

Keywords

IntubationAirtraqGeneral anesthesiaDifficult airway

Outcome Measures

Primary Outcomes (1)

  • Success

    Success of intubation within time frame

    180 seconds

Secondary Outcomes (2)

  • Number of attempts

    180 seconds

  • Number of injuries

    180 seconds

Study Arms (2)

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

Tracheal intubationDEVICE

tracheal intubation with Airtraq sp vs Airtraq mobile

Tracheal intubation with Airtraq MobileTracheal intubation with Airtraq sp

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt of Anesthesiology, University of Lausanne CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 26161393BACKGROUND

MeSH Terms

Conditions

Nasal ObstructionOsteoarthritis

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Patrick Schoettker, MD, PD

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PD

Study Record Dates

First Submitted

July 27, 2015

First Posted

July 29, 2015

Study Start

August 1, 2015

Primary Completion

November 5, 2017

Study Completion

November 5, 2017

Last Updated

January 2, 2018

Record last verified: 2017-12

Locations

CH(1)