Palpation Versus 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

NCT05679128

Collaborator

(none)

Enrollment

Arms

1.9

Anticipated Duration (Months)

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 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: identification of the cricothyroid membrane using Palpation Diagnostic Test: Identification of the cricothyroid membrane using ultrasonography	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomised to either "palpation" or "ultrasonography" The participants are thus arandomised 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 arandomised 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 Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Experimental: ultrasonography

Ultrasonography used to identify the cricothyroid membrane

Diagnostic Test: Identification of the cricothyroid membrane using ultrasonography

identification of the cricothyroid membrane, using ULTRASONOGRAPHY, 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 identifications of the location of the cricothyroid membrane made by the participants, that is actually correct. ie the succesrate of correct identification.

Secondary Outcome Measures

Time taken to identification of the estimated location of the cricothyroid membrane. [up to 3 minutes]
The time elapsing from the participants initiate their attempt at identificating the cricothyroid membrane until they have finished their attempt at identifying the cricothyroid membrane.

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: unwillingness to participate

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Seltz Kristensen, Head of Airway Management development, Consultant anaesthesiologist, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT05679128

Other Study ID Numbers:

Devtrach1

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 10, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Study Results

No Results Posted as of Jan 10, 2023