Infrared Transillumination of the Front of the Neck (IRRIS)

Infrared Transillumination of the Front of the Neck as an Aid for Awake Intubation

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.

Study Overview

• Status: Completed
• Conditions: Tracheal Intubation
• Intervention / Treatment: Procedure: Tracheal intubation by endoscopy with flexible bronchoscope

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fraction of cases where the blinking light is seen before the vocal cords are seen	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 -	1 day of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1 day of the procedure
Time from the tip of the flexible scope passes the teeth until vocal cords are seen	Time measured from the tip of the flexible scope passes the teeth until the vocal cords are seen	1 day of the procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from the tip of the flexible scope passes the teeth until the blinking light is seen	Time measured from the tip of the flexible scope passes the teeth until the blinking light is seen	1 day of the procedure
Time from the tip of the flexible scope passes the teeth until it is at the level of the mid trachea, trachea rings are seen	Time measured from the tip of the flexible scope passes the teeth until it is at the level of the mid trachea, trachea rings are seen	1 day of the procedure
Number of times that the flexible scope is pulled backwards	Counting the number of times that the flexible scope is pulled backwards	1 day of the procedure
Number of times that the flexible scope is reinserted past the teeth	Counting the number of times that the flexible scope is reinserted past the teeth	1 day of the procedure
Number of times that the flexible scope touches the mucosa until the tip is in the mid-trachea	Counting the Number of times that the flexible scope touches the mucosa until the tip is in the mid-trachea	1 day of the procedure
Time from the flexible scope passes the teeth until a carbon dioxide (CO2) curve is seen	Measuring the time from the flexible scope passes the teeth until a CO2 curve is seen on the capnograph	1 day of the procedure
Oxygen saturation	Oxygen saturation measured with pulse oximetry without added oxygen, with nasal oxygen, and the lowest value measured during the whole procedure.	1 day of the procedure
The operators evaluation of the ease of seeing the entrance to the trachea (at the level of the vocal cords)	The operators evaluation of the ease of seeing the entrance to the trachea (at the level of the vocal cords), measured on a scale from 1-10, 1=impossible, 10= very easy)	1 day of the procedure
If the operator means that the blinking infra-red guidance is beneficial for the procedure,	If the operator means that the blinking infra-red guidance is beneficial for the procedure, from 1 to 10, where 1= Not beneficial, 10 = extremely beneficial	1 day of the procedure
If the operator can distinguish the light from trachea fro the surrounding structures?	If the operator can distinguish the light from trachea fro the surrounding structures? On a scale from 1 to 10, 1= Not distinguishable, 10 = Clearly distinguishable	1 day of the procedure
Operators evaluation about the ease of using the blinking light as a guide for insertion of the insertion cord of the flexible scope	Operators evaluation about the ease of using the blinking light as a guide for insertion of the insertion cord of the flexible scope. On a scale from 1-10, 1= Very difficult, 10 = very easy	1 day of the procedure
Fraction pf cases where there is redness of the skin on the anterior neck	Observation of the skin on the anterior neck immediately after removal of the light-source, and one hour after arrival in the post-operative-recovery unit.	1 day of the procedure
Time for ultrasound-guided identification of the cricothyroid membrane and for cannula cricothyroidotomy	Time for ultrasound-guided identification of the cricothyroid membrane and for cannula cricothyroidotomy, measured on video of the procedure	1 day of the procedure

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Michael S Kristensen, MD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): January 6, 2020
• Study Completion (ACTUAL): January 6, 2020

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (ACTUAL): April 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: H-18038322 IRRIS

Drug and device information, study documents

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