NCT02159768

Brief Summary

The Airtraq is a battery powered single use optical laryngoscope with a channel to hold and guide the tracheal tube into the trachea. It enables tracheal intubation in patients with normal and difficult airways, by enabling laryngoscopy without neck movement. As a single use device, it is cost effective to have these placed in emergency equipment kits, and for use by emergency and military personnel. However, it does have several limitations. The Airtraq requires the user to place his/her eye to the eyepiece in order to see the advancement of the laryngoscope and the tracheal tube, which may be difficult if the patient is on the ground or in emergency scenarios. Only the user can see through the eyepiece and any assistants are unable to view the larynx, this makes it difficult for assistants to help the operator. Many handphones now incorporate high quality cameras. In this study, we will evaluate the effectiveness of using the iPhone to aid laryngoscopy with the Airtraq optical laryngoscope during laryngoscopy and intubation in 30 patients presenting for elective surgery under general anaesthesia. We have manufactured an attachment that fits over the eyepiece of the Airtraq, to hold an iPhone to the eyepiece. This will enable to operator and assistants to simultaneously view the insertion of the Airtraq, view the larynx and view the passage of the tracheal tube into the trachea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 22, 2016

Completed
Last Updated

February 22, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

June 9, 2014

Results QC Date

October 25, 2015

Last Update Submit

January 24, 2016

Conditions

Keywords

tracheal intubation

Outcome Measures

Primary Outcomes (1)

  • Visualization of Larynx With the Airtraq Laryngoscope and Handphone

    The efficacy of viewing the larynx via the handphone attached to the Airtraq laryngoscope will be assessed.

    Intra operative

Secondary Outcomes (1)

  • Transmission of Airtraq View of Larynx

    Intra operative measurement, time frame within 5 minutes

Study Arms (1)

Airtraq visualization

EXPERIMENTAL

Larynx visualization with Airtraq and attached handphone

Device: Airtraq visualization

Interventions

Larynx visualization with Airtraq and attached handphone

Also known as: Airtraq Avant
Airtraq visualization

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients requiring general anaesthesia for elective surgery and who require tracheal intubation as part of the anaesthesia technique.
  • American Society of Anesthesiologists Class I to III physiological status.

You may not qualify if:

  • Children Pregnant patients Patients who have not fasted for at least 6 hours pre surgery Patients at risk of regurgitation and aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

Results Point of Contact

Title
Senior Consultant
Organization
National University Hospital

Study Officials

  • Eugene H Liu, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

June 10, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 22, 2016

Results First Posted

February 22, 2016

Record last verified: 2016-01

Locations