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

October 14, 2023 updated by: Michael Seltz Kristensen, Rigshospitalet, Denmark

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2000
        • Rigshospitalet, department of anaesthesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Participants in a course of airway management -

Exclusion Criteria: Exclusion Criteria: unwillingness to participate

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct identification of the cricothyroid membrane within a minute
Time Frame: 1 minute
The fraction of correct identifications of the location of the cricothyroid membrane
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct identification of the sagittal plane within the airway
Time Frame: 1 minute
The fraction of identifications that were within the sagittal boundaries of the trachea
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Michael Kristensen, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2023

Primary Completion (Estimated)

December 20, 2023

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

October 14, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Devtrach2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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