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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04991545
Enrollment
30
Registered
2021-08-05
Start date
2021-01-13
Completion date
2022-01-01
Last updated
2021-08-05

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

Conditions

Airway Morbidity, Covid19, Trachea

Keywords

Infra-Red Illumination, Retrograde Transcutaneous, videoscope-tracheal Intubation

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. x

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

Interventions

DEVICEApplication of Infrared (Active IRD/ IRRIS) device

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: 1. Group A: control group 2. Group B: Intervention group using Infrared

Sponsors

Hamad Medical Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
infrared red light on the performance of video-laryngoscopy intubation and its impact on first pass successDuring procedure timeThe 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

MeasureTime frameDescription
Visibility of the glottic entranceDuring procedure timeVisibility of the glottic entrance during intubation
Time to recognize the illuminated laryngeal inlet.one yearTime to recognize the illuminated laryngeal inlet.
Number of intubation attempt.During procedure timeNumber of intubation attempt by the experience staff.
Correct intubationone yearRecognize the correct intubation pathway by other confirmatory tests
Alternative techniques of intubation.During procedure timeAlternative techniques of intubation if used after failure of primary equipment
Safety of Infra RedDuring procedure timeSafety: Presence and severity of skin lesion that might be associated at device application site. (Discomfort, pressure sign, irritation, redness, burn)
Types of video laryngoscopyDuring procedure timeTypes of video laryngoscopy used

Countries

Qatar

Contacts

Primary ContactNabil Shallik
nshallik@hamad.qa+97444393817

Outcome results

None listed

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