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Infrared Transillumination of the Front of the Neck

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03930550
Acronym
IRRIS
Enrollment
24
Registered
2019-04-29
Start date
2019-05-01
Completion date
2020-01-06
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal Intubation

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.

Interventions

PROCEDURETracheal 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

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Fraction of cases where the blinking light is seen before the vocal cords are seen1 day of the procedureThe 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

MeasureTime frameDescription
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 larynx1 day of the procedureThe 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 seen1 day of the procedureTime measured from the tip of the flexible scope passes the teeth until the vocal cords are seen

Other

MeasureTime frameDescription
Time from the tip of the flexible scope passes the teeth until the blinking light is seen1 day of the procedureTime measured from the tip of the flexible scope passes the teeth until the blinking light is seen
Time from the tip of the flexible scope passes the teeth until it is at the level of the mid trachea, trachea rings are seen1 day of the procedureTime 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
Number of times that the flexible scope is pulled backwards1 day of the procedureCounting the number of times that the flexible scope is pulled backwards
Number of times that the flexible scope is reinserted past the teeth1 day of the procedureCounting the number of times that the flexible scope is reinserted past the teeth
Number of times that the flexible scope touches the mucosa until the tip is in the mid-trachea1 day of the procedureCounting the Number of times that the flexible scope touches the mucosa until the tip is in the mid-trachea
Oxygen saturation1 day of the procedureOxygen saturation measured with pulse oximetry without added oxygen, with nasal oxygen, and the lowest value measured during the whole procedure.
If the operator can distinguish the light from trachea fro the surrounding structures?1 day of the procedureIf 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
Operators evaluation about the ease of using the blinking light as a guide for insertion of the insertion cord of the flexible scope1 day of the procedureOperators 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
Fraction pf cases where there is redness of the skin on the anterior neck1 day of the procedureObservation 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.
Time for ultrasound-guided identification of the cricothyroid membrane and for cannula cricothyroidotomy1 day of the procedureTime for ultrasound-guided identification of the cricothyroid membrane and for cannula cricothyroidotomy, measured on video of the procedure
Time from the flexible scope passes the teeth until a carbon dioxide (CO2) curve is seen1 day of the procedureMeasuring the time from the flexible scope passes the teeth until a CO2 curve is seen on the capnograph
The operators evaluation of the ease of seeing the entrance to the trachea (at the level of the vocal cords)1 day of the procedureThe 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)
If the operator means that the blinking infra-red guidance is beneficial for the procedure,1 day of the procedureIf 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026