NCT05679128

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

November 17, 2022

Last Update Submit

January 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time taken to identification of the estimated location of the cricothyroid membrane.

    up to 3 minutes

Study Arms (2)

palpation

ACTIVE COMPARATOR

digital palpation used to identify the cricothyroid membrane

Diagnostic Test: identification of the cricothyroid membrane using Palpation

ultrasonography

EXPERIMENTAL

Ultrasonography used to identify the cricothyroid membrane

Diagnostic Test: Identification of the cricothyroid membrane using ultrasonography

Interventions

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

palpation

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

ultrasonography

Eligibility Criteria

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

You may qualify if:

  • Participants in a course of airway management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lohse R, Wagner N, Kristensen MS. Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx: A Randomized Trial. Anesth Analg. 2024 Jul 1;139(1):195-200. doi: 10.1213/ANE.0000000000006867. Epub 2024 Jan 31.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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 membrane
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Airway Management development, Consultant anaesthesiologist

Study Record Dates

First Submitted

November 17, 2022

First Posted

January 10, 2023

Study Start

January 1, 2023

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share