Airway ManagementDevtrach2NCT06092229
Palpation Versus TACA- Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx
A study testing Palpation and Ultrasonography with TACA approach in people with Airway Management, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Airway Management
- What is being tested?
- Palpation and Ultrasonography with TACA approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Nov 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: Participants in a course of airway management -
Exclusion Criteria: Exclusion Criteria: unwillingness to participate
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Palpation Versus TACA ("Thyroid-Airline-Cricoid-Airline") 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 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
Read the detailed description
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.
The test persons are randomised to use other palpation or ultrasonography. Al attempts are video-taped
- Conditions
- Airway Management
- Being tested
- Palpation, Ultrasonography with TACA approach
- Keywords
- Airway Management, cricothyrotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalpationDiagnostic test
identification of the cricothyroid using PALPATION, a procedure used to prepare for front of neck airway access
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
| Study group | Role | What they receive |
|---|---|---|
| Palpation | Active comparator | digital palpation used to identify the cricothyroid membrane Receives: Diagnostic Test: Palpation |
| Ultrasonography | Experimental | Ultrasonography (TACA approach) used to identify the cricothyroid membrane Receives: Diagnostic Test: Ultrasonography with TACA approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct identification of the cricothyroid membrane within a minute
The fraction of correct identifications of the location of the cricothyroid membrane
Measured: 1 minute
Secondary outcomes (1)
Correct identification of the sagittal plane within the airway
The fraction of identifications that were within the sagittal boundaries of the trachea
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start30 Nov 2023 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Seltz Kristensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael Kristensen, MD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092229
- Sponsor's protocol ID
- Devtrach2
- Acronym
- Devtrach2
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palpation Versus TACA ("Thyroid-Airline-Cricoid-Airline") Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx
- ClinicalTrials.gov ID
- NCT06092229
- Acronym / sponsor ID
- Devtrach2 / Devtrach2
- Conditions
- Airway Management
- Keywords
- Airway Management, cricothyrotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
The test persons are randomised to use other palpation or ultrasonography. Al attempts are video-taped
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Palpation | Active comparator | Diagnostic Test: Palpationdigital palpation used to identify the cricothyroid membrane |
| Ultrasonography | Experimental | Diagnostic Test: Ultrasonography with TACA approachUltrasonography (TACA approach) used to identify the cricothyroid membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palpationidentification of the cricothyroid using PALPATION, a procedure used to prepare for front of neck airway access | Diagnostic test | Palpation |
| Ultrasonography with TACA approachidentification of the cricothyroid membrane, using ULTRASONOGRAPHY with TACA approach , a procedure used to prepare for front of neck airway access | Diagnostic test | Ultrasonography |
Primary outcome
Correct identification of the cricothyroid membrane within a minute
Time frame: 1 minute
The fraction of correct identifications of the location of the cricothyroid membrane
1 secondary outcome
Correct identification of the sagittal plane within the airway
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kristensen, MD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palpation and Ultrasonography with TACA approach in people with Airway Management, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Kristensen, MD (004535458033, michael.seltz.kristensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct identification of the cricothyroid membrane within a minute (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.