Feasibility of the Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation

Hamad Medical Corporation (HMC)

Status: Unknown

Conditions: Trachea; Covid19; Airway Morbidity

Treatments: Device: Application of Infrared (Active IRD/ IRRIS) device

Study type: Interventional

Funder types: Industry

Identifiers

NCT04991545

MRC-05-088

Details and patient eligibility

About

Airway securing through the placement of an endotracheal tube continues to be the definitive and the global standard management. The successful first attempt is aimed to avoid the consequences of multiple intubation trials as bleeding, tissue swelling, and airway contamination from gastric content that led to considerable morbidity and mortality. Visualization of the larynx and the glottic opening is the key to first-pass success requiring long-term training and availability of specific equipment concerned to that. For confirmation of the position endotracheal tube or its displacement, various clinical and equipment aids to that which are not valid or limited in different scenarios. Video laryngoscopes (VL) have been proposed to improve laryngeal visualization, hence a higher first-pass success rate accomplished. Despite that, there are limitations of video laryngoscope use in different circumstances that requiring adding of other aids to facilitate endotracheal intubation.

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Full description

Airway securing through the placement of an endotracheal tube continues to be the definitive and the global standard management. The successful first attempt is aimed to avoid the consequences of multiple intubation trials as bleeding, tissue swelling, and airway contamination from gastric content that led to considerable morbidity and mortality. Visualization of the larynx and the glottic opening is the key to first-pass success requiring long-term training and availability of specific equipment concerned to that. For confirmation of the position endotracheal tube or its displacement, various clinical and equipment aids to that which are not valid or limited in different scenarios. Video laryngoscopes (VL) have been proposed to improve laryngeal visualization, hence a higher first-pass success rate accomplished. Despite that, there are limitations of video laryngoscope use in different circumstances that requiring adding of other aids to facilitate endotracheal intubation.

The proposal of this study is to assess the feasibility and the impact of infrared/near-infrared (IRD) light on the performance of video-laryngoscopy and reduction of the time needed for endotracheal intubation and increase the credibility of the device.

Data-collection will be started after induction of the anesthesia and ended at the confirmation of endotracheal tube position

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age above 18 years
• General anesthesia that needs endotracheal intubation
• All Mallampati score 1-3
• ASA physical status 1-3

Exclusion criteria

• Refuse or unable to sign the consent.
• Pregnancy
• Emergency cases
• History of or expected difficult intubation
• Maxillofacial abnormality or trauma
• Age below 18 years
• Rapid sequence induction
• Skin disorders and skin light sensitivity (SLE, Lupus ....)
• Impaired head and neck mobility
• Scars or skin injuries at the neck

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group A: control group (intubation without IRD/IRRIS device)

No Intervention group

Description:

Group A = control group (intubation without IRD/IRRIS device) (15 subjects) The first operator experienced with video-laryngoscopy intubation will do the endotracheal intubation after induction of anesthesia.

Intervention group using Infrared (Active IRD/ IRRIS) device

Experimental group

Description:

Group B = intervention group using Infrared active IRD/IRRIS device (15 subjects) Before inducing anesthesia, the second operator will open the randomization envelope and adhere IRRIS/IRD device to the anterior skin of the neck above the sternal notch according to the group of patients. After confirming lack of discomfort during application of the IRRIS/IRD device, anesthesia will be induced

Treatment:

Device: Application of Infrared (Active IRD/ IRRIS) device