Infrared Transillumination of the Front of the Neck

Overview

Infrared light is applied to the front of the neck of patients for awake flexible optical intubation. The infrared light can be detected by the camera at the tip of the flexible video-bronchoscope. The flexible scope is introduced into the trachea with or without the aid of the blinking infra red light and the ease of placement of the flexible scope is studied.

Full Title of Study: “Infrared Transillumination of the Front of the Neck as an Aid for Awake Intubation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2019

Detailed Description

The investigators study patients for anaesthesia who will need endotracheal intubation and in whom the intubation is predicted to become difficult so that an awake flexible-video-scope-guided intubation is chosen.

Infrared light is applied to the front of the neck of patients for awake flexible optical intubation. The infrared light can be detected by the camera at the tip of the flexible video-bronchoscope. The flexible scope is introduced into the trachea with or without the aid of the blinking infra red light and the ease of placement of the flexible scope is studied.

Interventions

  • Procedure: Tracheal intubation by endoscopy with flexible bronchoscope
    • A blinking infrared light source is placed on the anterior neck at the level of the cricothyroid membrane to serve as a guide to facilitate finding the way to the trachea

Arms, Groups and Cohorts

  • Experimental: Infrared guidance first
    • In this arm the infra red guidance is applied to the first passage of the flexible scope to the trachea. The second passage of the flexible scope is without the infrared light
  • Active Comparator: Infrared guidance last
    • In this arm NO infra red guidance is applied to the first passage of the flexible scope to the trachea. The second passage of the flexible scope is with the infrared light as guide

Clinical Trial Outcome Measures

Primary Measures

  • Fraction of cases where the blinking light is seen before the vocal cords are seen
    • Time Frame: 1 day of the procedure
    • The flexible scope is entered into the airway twice, . It is noted from watching the videos of the procedures if the blinking light or the vocal cords are seen first -

Secondary Measures

  • Fraction of cases where the blinking light is seen from the teeth, the mouth, the pharynx and the larynx and the fra fraction of cases where the vocal cords are seen from the teeth, the mouth, the pharynx and the larynx
    • Time Frame: 1 day of the procedure
    • The flexible scope is entered into the airway twice, one time with and one time without the blinking light on the front of the neck. It is noted from watching the videos of the procedures if the blinking light or the vocal cords are seen first – and from which anatomical location it is seen.
  • Time from the tip of the flexible scope passes the teeth until vocal cords are seen
    • Time Frame: 1 day of the procedure
    • Time measured from the tip of the flexible scope passes the teeth until the vocal cords are seen

Participating in This Clinical Trial

Inclusion Criteria

  • Patients scheduled for awake tracheal intubation over the insertion cord of a flexible video-trachea-bronchoscope.

Exclusion Criteria

  • Age < 18 years
  • Patients at high risk of aspiration of gastric content
  • Patients with hypoxia, saturation < 90 % on ambient air
  • Patients with audible stridor at rest
  • American Society of Anesthesiology (ASA) physical class > 3
  • contraindication for trans-crico-thyoid-membrane puncture (cancer, infection on the site, severely coagulopathies, inability to identify the crico-thyroid membrane)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael Seltz Kristensen, Principal Investigator – Rigshospitalet, Denmark
  • Overall Official(s)
    • Michael S Kristensen, MD, Principal Investigator, Rigshospitalet, Denmark
  • Overall Contact(s)
    • Michael S Kristensen, MD, 0045 35458033, michael.seltz.kristensen@regionh.dk

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