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

Study Overview

• Status: Not yet recruiting
• Conditions: Airway Management
• Intervention / Treatment: Diagnostic test: identification of the cricothyroid membrane using Palpation; Diagnostic test: Identification of the cricothyroid membrane using ultrasonography

Detailed Description

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.

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants in a course of airway management

Exclusion Criteria: unwillingness to participate

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct identification of the cricothyroid membrane within a 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.	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time taken to identification of the estimated location of the cricothyroid membrane.	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.	up to 3 minutes

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Devtrach1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No