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

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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Study Overview

• Status: Recruiting
• Conditions: Covid19; Airway Morbidity; Trachea
• Intervention / Treatment: Device: Application of Infrared (Active IRD/ IRRIS) device

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nabil Shallik; Phone Number: +97444393817; Email: nshallik@hamad.qa

Study Locations

• Qatar
  • Doah
    • Doha, Doah, Qatar, 3050
      • Recruiting
      • ACC&HGH, Hamad Medical Corporation
      • Contact: Nabil Shallik, M.D.; Phone Number: 9745543926; Email: nshallik@outlook.com
      • Principal Investigator: Elsayyed Elkarta, M.D.
      • Sub-Investigator: Odai Khammash, MBBCh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: 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.
EXPERIMENTAL: 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	Device: 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: Group A: control group; Group B: Intervention group using Infrared

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation

Publications and helpful links

General Publications

• Simpson GD, Ross MJ, McKeown DW, Ray DC. Tracheal intubation in the critically ill: a multi-centre national study of practice and complications. Br J Anaesth. 2012 May;108(5):792-9. doi: 10.1093/bja/aer504. Epub 2012 Feb 6.
• Sakles JC, Chiu S, Mosier J, Walker C, Stolz U. The importance of first pass success when performing orotracheal intubation in the emergency department. Acad Emerg Med. 2013 Jan;20(1):71-8. doi: 10.1111/acem.12055.
• Webb RK, Currie M, Morgan CA, Williamson JA, Mackay P, Russell WJ, Runciman WB. The Australian Incident Monitoring Study: an analysis of 2000 incident reports. Anaesth Intensive Care. 1993 Oct;21(5):520-8. doi: 10.1177/0310057X9302100507.
• Duggan LV, Mastoras G, Bryson GL. Tracheal intubation in patients with COVID-19. CMAJ. 2020 Jun 1;192(22):E607. doi: 10.1503/cmaj.200650. Epub 2020 May 1. No abstract available.
• Knapp S, Kofler J, Stoiser B, Thalhammer F, Burgmann H, Posch M, Hofbauer R, Stanzel M, Frass M. The assessment of four different methods to verify tracheal tube placement in the critical care setting. Anesth Analg. 1999 Apr;88(4):766-70. doi: 10.1097/00000539-199904000-00016.
• Nemec D, Austin PN, Silvestro LS. Methods to Improve Success With the GlideScope Video Laryngoscope. AANA J. 2015 Dec;83(6):389-97.
• 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.
• 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.
• Wayne MA, McDonnell M. Comparison of traditional versus video laryngoscopy in out-of-hospital tracheal intubation. Prehosp Emerg Care. 2010 Apr-Jun;14(2):278-82. doi: 10.3109/10903120903537189.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: July 28, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (ACTUAL): August 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Infra-Red Illumination; Retrograde Transcutaneous; videoscope-tracheal Intubation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Tracheal Diseases
• Other Study ID Numbers: MRC-05-088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the data after IRB approval
• IPD Sharing Time Frame: After IRB approval directly
• IPD Sharing Access Criteria: Website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No