Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-05 @ 5:44 PM
Study NCT ID:
NCT02159768
Status:
COMPLETED
Last Update Posted:
2016-02-22
First Post:
2014-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission
Sponsor:
National University Hospital, Singapore
Organization:
Study Overview
Official Title:
Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: