NCT03930550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

April 24, 2019

Last Update Submit

February 22, 2021

Conditions

Tracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

    1 day of the procedure

  • Time from the tip of the flexible scope passes the teeth until vocal cords are seen

    1 day of the procedure

Other Outcomes (13)

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

    1 day of the procedure

  • 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

    1 day of the procedure

  • Number of times that the flexible scope is pulled backwards

    1 day of the procedure

  • +10 more other outcomes

Study Arms (2)

Infrared guidance first

EXPERIMENTAL

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

Procedure: Tracheal intubation by endoscopy with flexible bronchoscope

Infrared guidance last

ACTIVE COMPARATOR

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

Procedure: Tracheal intubation by endoscopy with flexible bronchoscope

Interventions

Tracheal intubation by endoscopy with flexible bronchoscopePROCEDURE

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 firstInfrared guidance last

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for awake tracheal intubation over the insertion cord of a flexible video-trachea-bronchoscope.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 36690598DERIVED

Study Officials

  • Michael S Kristensen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2019

First Posted

April 29, 2019

Study Start

May 1, 2019

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

DK(1)