Clinical trial NCT04991545: Feasibility of the Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation
Official title: Feasibility of the RetrogradeTranscutaneous Infra-Red Illumination for Facilitation of Video Scope-tracheal Intubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Morbidity
Covid19
Trachea
Keywords: Infra-Red Illumination
Retrograde Transcutaneous
videoscope-tracheal Intubation
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass success
timeFrame: During procedure time
Secondary outcomes:
measure: Visibility of the glottic entrance
timeFrame: During procedure time
measure: Time to recognize the illuminated laryngeal inlet.
timeFrame: one year
measure: Correct intubation
timeFrame: one year
measure: Number of intubation attempt.
timeFrame: During procedure time
measure: Types of video laryngoscopy
timeFrame: During procedure time
measure: Alternative techniques of intubation.
timeFrame: During procedure time
measure: Safety of Infra Red
timeFrame: During procedure time
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: ACC&HGH, Hamad Medical Corporation
state: Doah
Study officials:
affiliation: Hamad Medical Corporation - HMC
name: Nabil Shallik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kristensen MS, Fried E, Biro P. Infrared Red Intubation System (IRRIS) guided flexile videoscope assisted difficult airway management. Acta Anaesthesiol Scand. 2018 Jan;62(1):19-25. doi: 10.1111/aas.13016. Epub 2017 Oct 24.
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