Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission

NCT ID: NCT02159768

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-08-31

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.

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.

Conditions

Anaesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Airtraq visualization

Larynx visualization with Airtraq and attached handphone

Group Type: EXPERIMENTAL

Airtraq visualization

Intervention Type: DEVICE

Larynx visualization with Airtraq and attached handphone

Interventions

Airtraq visualization

Larynx visualization with Airtraq and attached handphone

Intervention Type: DEVICE

Other Intervention Names

Airtraq Avant

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eugene H Liu, MD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

2013/00376

Identifier Type: -

Identifier Source: org_study_id