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

Study Overview
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Brief Summary
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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. x

Detailed Description
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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

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

Conditions
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Airway Morbidity, Covid19, Trachea

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A: control group (intubation without IRD/IRRIS device)<br>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. | |
| Experimental: Intervention group using Infrared (Active IRD/ IRRIS) device<br>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 | Device: Application of Infrared (Active IRD/ IRRIS) device<br>* The first operator experienced with video-laryngoscopy intubation will do 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, After complete relaxation, Laryngoscopy will be performed by the first operator using video laryngoscope (Glidescope Verathon Medical, BC, Canada or C-Mac Storz, Germany) to insert the tracheal tube. The endotracheal tube will be armed with a malleable stylet and to be molded to a curved 'hockey stick or the same curve of the laryngoscopic blade's shape. We will divide the patient according to device into two groups: Group A: control group Group B: Intervention group using Infrared<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass success | 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 | During procedure time | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infra-Red Illumination, Retrograde Transcutaneous, videoscope-tracheal Intubation