Infrared Transillumination of the Front of the Neck

Tracheal Intubation Clinical Trial

— IRRIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930550
• Other study ID #: H-18038322 IRRIS
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: January 6, 2020

Study information

• Verified date: February 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tracheal Intubation

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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