Clinical trial NCT02159768: Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission
Official title: Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaesthesia
Keywords: tracheal intubation
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visualization of Larynx With the Airtraq Laryngoscope and Handphone
timeFrame: Intra operative
Secondary outcomes:
measure: Transmission of Airtraq View of Larynx
timeFrame: Intra operative measurement, time frame within 5 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Eugene H Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: