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

NCT04991545 | Unknown DMC

• 1 other identifier: MRC-05-088
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Airway Morbidity; Covid19; Trachea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Visibility of the glottic entrance

  During procedure time

• Time to recognize the illuminated laryngeal inlet.

  one year

• Correct intubation

  one year

• Number of intubation attempt.

  During procedure time

• Types of video laryngoscopy

  During procedure time

Study Arms (2)

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

NO INTERVENTION

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.

Intervention group using Infrared (Active IRD/ IRRIS) device

EXPERIMENTAL

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

Interventions

Application of Infrared (Active IRD/ IRRIS) device 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 group using Infrared (Active IRD/ IRRIS) device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18 years
• General anesthesia that needs endotracheal intubation
• All Mallampati score 1-3
• ASA physical status 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

ACC&HGH, Hamad Medical Corporation

Doha, Doah, 3050, Qatar

RECRUITING

Related Publications (9)

• 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.

  PMID: 22315326 RESULT

• 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.

  PMID: 23574475 RESULT

• 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.

  PMID: 8273871 RESULT

• 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.

  PMID: 32357995 RESULT

• 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.

  PMID: 10195521 RESULT

• Nemec D, Austin PN, Silvestro LS. Methods to Improve Success With the GlideScope Video Laryngoscope. AANA J. 2015 Dec;83(6):389-97.

  PMID: 26742332 RESULT

• 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.

  PMID: 26742405 RESULT

• 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.

  PMID: 29063583 RESULT

• 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.

  PMID: 20199237 RESULT

MeSH Terms

Conditions

COVID-19; Tracheal Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nabil Shallik, M.D.

  Hamad Medical Corporation - HMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil Shallik

CONTACT

+97444393817; nshallik@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: January 13, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After IRB approval directly
• Access Criteria: Website

Locations

QA (1)