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

Not Applicable

• Conditions: Airway Morbidity; Covid19; Trachea
• Interventions: Device: Application of Infrared (Active IRD/ IRRIS) device

• Registration Number: NCT04991545
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

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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Detailed 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

Study Timeline

• Study Start: 2021-01-13
• Status Verified: 2021-07
• Study First Submitted: 2021-07-28
• Study First Submitted QC: 2021-07-28
• Last Update Submitted: 2021-07-28
• Study First Posted: 2021-08-05
• Last Update Posted: 2021-08-05
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Intervention group using Infrared (Active IRD/ IRRIS) device	Application of Infrared (Active IRD/ IRRIS) device	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

Primary Outcome Measures

Name	Time	Method
infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass success	During procedure time	The primary endpoint will be the feasibility of infrared/near-red light on the performance of video-laryngoscopy tracheal intubation and its impact on first pass success

Secondary Outcome Measures

Name	Time	Method
Safety of Infra Red	During procedure time	Safety: Presence and severity of skin lesion that might be associated at device application site. (Discomfort, pressure sign, irritation, redness, burn)
Visibility of the glottic entrance	During procedure time	Visibility of the glottic entrance during intubation
Time to recognize the illuminated laryngeal inlet.	one year	Time to recognize the illuminated laryngeal inlet.
Correct intubation	one year	Recognize the correct intubation pathway by other confirmatory tests
Number of intubation attempt.	During procedure time	Number of intubation attempt by the experience staff.
Types of video laryngoscopy	During procedure time	Types of video laryngoscopy used
Alternative techniques of intubation.	During procedure time	Alternative techniques of intubation if used after failure of primary equipment

Trial Locations

Locations (1)

ACC&HGH, Hamad Medical Corporation; 🇶🇦 Doha, Doah, Qatar