NCT06092229

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

October 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

20 days

First QC Date

October 14, 2023

Last Update Submit

October 14, 2023

Conditions

Airway Management

Keywords

Airway Management, cricothyrotomy

Outcome Measures

Primary Outcomes (1)

  • Correct identification of the cricothyroid membrane within a minute

    The fraction of correct identifications of the location of the cricothyroid membrane

    1 minute

Secondary Outcomes (1)

  • Correct identification of the sagittal plane within the airway

    1 minute

Study Arms (2)

Palpation

ACTIVE COMPARATOR

digital palpation used to identify the cricothyroid membrane

Diagnostic Test: Palpation

Ultrasonography

EXPERIMENTAL

Ultrasonography (TACA approach) used to identify the cricothyroid membrane

Diagnostic Test: Ultrasonography with TACA approach

Interventions

PalpationDIAGNOSTIC_TEST

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

Palpation
Ultrasonography with TACA approachDIAGNOSTIC_TEST

identification of the cricothyroid membrane, using ULTRASONOGRAPHY with TACA approach , 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+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, department of anaesthesia

Copenhagen, 2000, Denmark

Location

MeSH Terms

Interventions

PalpationUltrasonography

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisDiagnostic Imaging

Study Officials

  • Michael Kristensen, MD

    Rigshospitalet, Denmark

    STUDY CHAIR

Central Study Contacts

Michael Kristensen, MD

CONTACT

004535458033michael.seltz.kristensen@regionh.dk

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 randomised 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
Consultant Anaesthetist

Study Record Dates

First Submitted

October 14, 2023

First Posted

October 23, 2023

Study Start

November 30, 2023

Primary Completion

December 20, 2023

Study Completion

February 28, 2024

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

DK(1)