Clinical trial NCT03930550: Infrared Transillumination of the Front of the Neck
Official title: Infrared Transillumination of the Front of the Neck as an Aid for Awake Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Fraction of cases where the blinking light is seen before the vocal cords are seen
timeFrame: 1 day of the procedure
Secondary outcomes:
measure: 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
timeFrame: 1 day of the procedure
measure: Time from the tip of the flexible scope passes the teeth until vocal cords are seen
timeFrame: 1 day of the procedure
Other outcomes:
measure: Time from the tip of the flexible scope passes the teeth until the blinking light is seen
timeFrame: 1 day of the procedure
measure: 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
timeFrame: 1 day of the procedure
measure: Number of times that the flexible scope is pulled backwards
timeFrame: 1 day of the procedure
measure: Number of times that the flexible scope is reinserted past the teeth
timeFrame: 1 day of the procedure
measure: Number of times that the flexible scope touches the mucosa until the tip is in the mid-trachea
timeFrame: 1 day of the procedure
measure: Time from the flexible scope passes the teeth until a carbon dioxide (CO2) curve is seen
timeFrame: 1 day of the procedure
measure: Oxygen saturation
timeFrame: 1 day of the procedure
measure: The operators evaluation of the ease of seeing the entrance to the trachea (at the level of the vocal cords)
timeFrame: 1 day of the procedure
measure: If the operator means that the blinking infra-red guidance is beneficial for the procedure,
timeFrame: 1 day of the procedure
measure: If the operator can distinguish the light from trachea fro the surrounding structures?
timeFrame: 1 day of the procedure
measure: Operators evaluation about the ease of using the blinking light as a guide for insertion of the insertion cord of the flexible scope
timeFrame: 1 day of the procedure
measure: Fraction pf cases where there is redness of the skin on the anterior neck
timeFrame: 1 day of the procedure
measure: Time for ultrasound-guided identification of the cricothyroid membrane and for cannula cricothyroidotomy
timeFrame: 1 day of the procedure
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Study officials:
affiliation: Rigshospitalet, Denmark
name: Michael S Kristensen, MD
role: PRINCIPAL_INVESTIGATOR
References: