Infrared Transillumination of the Front of the Neck

NCT ID: NCT03930550

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-01-06

Brief Summary

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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

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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.

Conditions

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Tracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Tracheal intubation by endoscopy with flexible bronchoscope

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Tracheal intubation by endoscopy with flexible bronchoscope

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Michael Seltz Kristensen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael S Kristensen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Kristensen MS, Hesselfeldt R, Brinkenfeldt HK, Biro P. Infrared flashing light through the cricothyroid membrane as guidance to awake intubation with a flexible bronchoscope: A randomised cross-over study. Acta Anaesthesiol Scand. 2023 Apr;67(4):432-439. doi: 10.1111/aas.14204. Epub 2023 Feb 2.

Reference Type DERIVED
PMID: 36690598 (View on PubMed)

Other Identifiers

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H-18038322 IRRIS

Identifier Type: -

Identifier Source: org_study_id

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