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

NCT ID: NCT04991545

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2022-01-01

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

Conditions

Airway Morbidity; Covid19; Trachea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group using 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

Group Type: EXPERIMENTAL

Application of Infrared (Active IRD/ IRRIS) device

Intervention Type: 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

Interventions

Application 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nabil Shallik, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation - HMC

Locations

ACC&HGH, Hamad Medical Corporation

Doha, Doah, Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

Nabil Shallik

Role: CONTACT

nshallik@hamad.qa

+97444393817

Facility Contacts

Nabil Shallik, M.D.

Role: primary

nshallik@outlook.com

9745543926

References

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Saima S, Asai T, Kimura R, Terada S, Arai T, Okuda Y. [Combined Use of a Videolaryngoscope and a Transilluminating Device for Intubation with Two Difficult Airways]. Masui. 2015 Oct;64(10):1045-7. Japanese.

Reference Type: RESULT

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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.

Reference Type: RESULT

PMID: 29063583 (View on PubMed)

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Reference Type: RESULT

PMID: 20199237 (View on PubMed)

Other Identifiers

MRC-05-088

Identifier Type: -

Identifier Source: org_study_id