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Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission

Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02159768
Enrollment
30
Registered
2014-06-10
Start date
2013-08-31
Completion date
2015-08-31
Last updated
2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia

Keywords

tracheal intubation

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.

Interventions

DEVICEAirtraq visualization

Larynx visualization with Airtraq and attached handphone

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visualization of Larynx With the Airtraq Laryngoscope and HandphoneIntra operativeThe efficacy of viewing the larynx via the handphone attached to the Airtraq laryngoscope will be assessed.

Secondary

MeasureTime frameDescription
Transmission of Airtraq View of LarynxIntra operative measurement, time frame within 5 minutesThe view of the larynx will be captured by the handphone attached to the Airtraq layryngoscope, and then transmitted to a second investigator.

Countries

Singapore

Participant flow

Recruitment details

Recruitment from 16 July 2014 to 27 July 2015, in hospital ward, before surgery and anesthesia.

Participants by arm

ArmCount
Airtraq Visualization
Larynx visualization with Airtraq and attached handphone Airtraq visualization: Larynx visualization with Airtraq and attached handphone
30
Total30

Baseline characteristics

CharacteristicAirtraq Visualization
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
4 Participants
Age, Categorical
Between 18 and 65 years
26 Participants
Age, Continuous40 years
STANDARD_DEVIATION 16.2
Region of Enrollment
Singapore
30 participants
Sex: Female, Male
Female
18 Participants
Sex: Female, Male
Male
12 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 30
serious
Total, serious adverse events
0 / 30

Outcome results

Primary

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.

Time frame: Intra operative

Population: Study participants in whom the Airtraq handphone visualization system was studied

ArmMeasureValue (NUMBER)
Airtraq VisualizationVisualization of Larynx With the Airtraq Laryngoscope and Handphone30 participants
Secondary

Transmission of Airtraq View of Larynx

The view of the larynx will be captured by the handphone attached to the Airtraq layryngoscope, and then transmitted to a second investigator.

Time frame: Intra operative measurement, time frame within 5 minutes

Population: The larynx could be visualized in all 30 patients using the handphone attached to the Airtraq. The images of the larynx could be transmitted to a remote assistant in all 30 patients.

ArmMeasureValue (NUMBER)
Airtraq VisualizationTransmission of Airtraq View of Larynx30 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026