Devtrach2: Palpation Versus TACA- Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06092229

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

21.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.

The ultrasonographic method to be used is the Thyroid-Airline-Cricoid-Airline (TACA) approach.

The larynx-model is deviated to one of the sides to simulate a patient with neck pathology

Condition or Disease	Intervention/Treatment	Phase
Airway Management	Diagnostic Test: Palpation Diagnostic Test: Ultrasonography with TACA approach	N/A

Detailed Description

test persons, anaesthesiologists will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.

The ultrasonographic method to be used is the Thyroid-Airline-Cricoid-Airline (TACA) approach.

The larynx-model is deviated to one of the sides to simulate a patient with neck pathology.

The test persons are randomised to use other palpation or ultrasonography. Al attempts are video-taped

Study Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomised to either "palpation" or "ultrasonography" The participants are thus randomised to use either "palpation" or to use "ultrasonography" to DIAGNOSE the position of the cricothyroid membranerandomised to either "palpation" or "ultrasonography" The participants are thus randomised to use either "palpation" or to use "ultrasonography" to DIAGNOSE the position of the cricothyroid membrane

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Palpation Versus TACA ("Thyroid-Airline-Cricoid-Airline") Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Dec 20, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Palpation digital palpation used to identify the cricothyroid membrane	Diagnostic Test: Palpation identification of the cricothyroid using PALPATION, a procedure used to prepare for front of neck airway access
Experimental: Ultrasonography Ultrasonography (TACA approach) used to identify the cricothyroid membrane	Diagnostic Test: Ultrasonography with TACA approach identification of the cricothyroid membrane, using ULTRASONOGRAPHY with TACA approach , a procedure used to prepare for front of neck airway access

Arm

Intervention/Treatment

Active Comparator: Palpation

digital palpation used to identify the cricothyroid membrane

Diagnostic Test: Palpation

identification of the cricothyroid using PALPATION, a procedure used to prepare for front of neck airway access

Experimental: Ultrasonography

Ultrasonography (TACA approach) used to identify the cricothyroid membrane

Diagnostic Test: Ultrasonography with TACA approach

identification of the cricothyroid membrane, using ULTRASONOGRAPHY with TACA approach , a procedure used to prepare for front of neck airway access

Outcome Measures

Primary Outcome Measures

Correct identification of the cricothyroid membrane within a minute [1 minute]
The fraction of correct identifications of the location of the cricothyroid membrane

Secondary Outcome Measures

Correct identification of the sagittal plane within the airway [1 minute]
The fraction of identifications that were within the sagittal boundaries of the trachea

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: Participants in a course of airway management -

Exclusion Criteria: Exclusion Criteria: unwillingness to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet, department of anaesthesia	Copenhagen		Denmark	2000

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Study Chair: Michael Kristensen, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Seltz Kristensen, Consultant Anaesthetist, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT06092229

Other Study ID Numbers:

Devtrach2

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Michael Seltz Kristensen, Consultant Anaesthetist, Rigshospitalet, Denmark

Airway Management, cricothyrotomy

Study Results

No Results Posted as of Oct 23, 2023