- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06701864
Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane of Distorted Neck-anatomy (DEVITRACH3)
Participants will be anesthesiologists, who will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.
The participants can choose either the "String of pearls" or Thyroid-Airline-Cricoid-Airline (TACA) for the ultrasonographic method to be used .
The silicone model of the neck is distorted with with the larynx deviated to one of the sides to simulate a patient with neck pathology.
Study Overview
Status
Intervention / Treatment
Detailed Description
Participants will be anesthesiologists, who will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.
The participants can choose either the "String of pearls" or Thyroid-Airline-Cricoid-Airline (TACA) for the ultrasonographic method to be used .
The silicone model of the neck is distorted with with the larynx deviated to one of the sides to simulate a patient with neck pathology.
The test persons are randomized to use other palpation or ultrasonography. All attempts are video-taped.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark
- Rigshospitalet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants in a airway management course
Exclusion Criteria:
- Unwillingness to participate
Study Plan
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
|
Identification of the cricothyroid membrane using PALPATION, a procedure used to prepare for front of neck airway access
|
|
Experimental: Ultrasound
Ultrasonography (either "String of pearls" or TACA approach) used to identify the cricothyroid membrane
|
Identification of the cricothyroid membrane, using ULTRASONOGRAPHY with either the "String of pearls" or TACA aproach as chosen by the participant , 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: Within 1 minute during procedure
|
The fraction of correct identifications of the location of the cricothyroid membrane
|
Within 1 minute during procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correct identification of the sagittal plane within the airway
Time Frame: Within 1 minute during procedure
|
The fraction of identifications that were within the sagittal boundaries of the trachea
|
Within 1 minute during procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F-22064259-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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