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Completed

NCT Number: NCT03930550

Infrared Transillumination of the Front of the Neck

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.

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Key information

Conditions

Tracheal Intubation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tracheal intubation by endoscopy with flexible bronchoscope

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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

Other outcomes

  1. Time from the tip of the flexible scope passes the teeth until the blinking light is seen

    Time frame: 1 day of the procedure

    Time measured from the tip of the flexible scope passes the teeth until the blinking light is seen

  2. 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 frame: 1 day of the procedure

    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

  3. Number of times that the flexible scope is pulled backwards

    Time frame: 1 day of the procedure

    Counting the number of times that the flexible scope is pulled backwards

  4. Number of times that the flexible scope is reinserted past the teeth

    Time frame: 1 day of the procedure

    Counting the number of times that the flexible scope is reinserted past the teeth

  5. Number of times that the flexible scope touches the mucosa until the tip is in the mid-trachea

    Time frame: 1 day of the procedure

    Counting the Number of times that the flexible scope touches the mucosa until the tip is in the mid-trachea

  6. Time from the flexible scope passes the teeth until a carbon dioxide (CO2) curve is seen

    Time frame: 1 day of the procedure

    Measuring the time from the flexible scope passes the teeth until a CO2 curve is seen on the capnograph

  7. Oxygen saturation

    Time frame: 1 day of the procedure

    Oxygen saturation measured with pulse oximetry without added oxygen, with nasal oxygen, and the lowest value measured during the whole procedure.

  8. The operators evaluation of the ease of seeing the entrance to the trachea (at the level of the vocal cords)

    Time frame: 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), measured on a scale from 1-10, 1=impossible, 10= very easy)

  9. If the operator means that the blinking infra-red guidance is beneficial for the procedure,

    Time frame: 1 day of 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

  10. If the operator can distinguish the light from trachea fro the surrounding structures?

    Time frame: 1 day of the procedure

    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

  11. Operators evaluation about the ease of using the blinking light as a guide for insertion of the insertion cord of the flexible scope

    Time frame: 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. On a scale from 1-10, 1= Very difficult, 10 = very easy

  12. Fraction pf cases where there is redness of the skin on the anterior neck

    Time frame: 1 day of the procedure

    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.

  13. Time for ultrasound-guided identification of the cricothyroid membrane and for cannula cricothyroidotomy

    Time frame: 1 day of the procedure

    Time for ultrasound-guided identification of the cricothyroid membrane and for cannula cricothyroidotomy, measured on video of the procedure

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: IRRIS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2019
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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