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Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission

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ClinicalTrials.gov Identifier: NCT02159768
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anaesthesia Device: Airtraq visualization Not Applicable

Detailed Description:

This study is a single-cohort study design. 30 patients undergoing elective surgery under general anaesthesia will be recruited. They will have endotracheal intubation done with the Airtraq optical laryngoscope and handphone camera assisted visualization.

The Airtraq optical laryngoscope fitted with the attachment holding the camera handphone will be prepared and loaded with an appropriately sized endotracheal tube. A standard general anaesthesia technique will be used. This will include standard monitoring including pulse oximetry, non-invasive blood pressure, ECG and capnography, all started before induction of anaesthesia. Anaesthesia will be induced with proprofol and fentanyl, and muscle relaxation with atracurium.

The airway management procedure will start after induction of anaesthesia and muscle relaxation. The Airtraq optical laryngoscope will be used. The Airtraq is fit with an attachment to hold the camera handphone, and loaded with an endotracheal tube. The Airtraq will be inserted and manipulated until the best view of the patient's laryngeal opening can be seen on the camera handphone screen. The endotracheal tube will then be placed in the patient's trachea and the cuff inflated. Successful intubation will be confirmed by 3-point auscultation and presence of end-tidal carbon dioxide tracing.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission
Study Start Date : August 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: Airtraq visualization
Larynx visualization with Airtraq and attached handphone
 Device: Airtraq visualization
Larynx visualization with Airtraq and attached handphone
Other Name: Airtraq Avant


Outcome Measures
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Primary Outcome Measures :
  1. Visualization of Larynx With the Airtraq Laryngoscope and Handphone [ Time Frame: Intra operative ]
    The efficacy of viewing the larynx via the handphone attached to the Airtraq laryngoscope will be assessed.


Secondary Outcome Measures :
  1. Transmission of Airtraq View of Larynx [ Time Frame: Intra operative measurement, time frame within 5 minutes ]
    The view of the larynx will be captured by the handphone attached to the Airtraq layryngoscope, and then transmitted to a second investigator.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159768


Locations
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Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
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Principal Investigator: Eugene H Liu, MD National University Hospital, Singapore
More Information
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02159768    
Other Study ID Numbers: 2013/00376
First Posted: June 10, 2014    Key Record Dates
Results First Posted: February 22, 2016
Last Update Posted: February 22, 2016
Last Verified: January 2016
Keywords provided by National University Hospital, Singapore:
tracheal intubation