Airway ManagementNCT05679128
Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx
A study testing identification of the cricothyroid membrane using Palpation and Identification of the cricothyroid membrane using ultrasonography in people with Airway Management, run by Copenhagen University Hospital, Rigshospitalet.
Trial 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 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?
- identification of the cricothyroid membrane using Palpation and Identification of the cricothyroid membrane using ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Mar 2023
- 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
Who may be able to join
- Participants in a course of airway management
Who cannot join
- -
About this study
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
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 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
- identification of the cricothyroid membrane using Palpation, Identification of the cricothyroid membrane using ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
identification of the cricothyroid membrane using PalpationDiagnostic test
identification of the cricothyroid using PALPATION, a procedure used to prepare for front of neck airway access
Identification of the cricothyroid membrane using ultrasonographyDiagnostic test
identification of the cricothyroid membrane, using ULTRASONOGRAPHY, 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: identification of the cricothyroid membrane using Palpation |
| ultrasonography | Experimental | Ultrasonography used to identify the cricothyroid membrane Receives: Diagnostic Test: Identification of the cricothyroid membrane using ultrasonography |
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 identifications of the location of the cricothyroid membrane made by the participants, that is actually correct. ie the succesrate of correct identification.
Measured: 1 minute
Secondary outcomes (1)
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.
Measured: up to 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 arandomised to use either "palpation" or to use "ultrasonography" to DIAGNOSE the position of the cricothyroid membrane
- Masking
- None (open label)
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679128
- Sponsor's protocol ID
- Devtrach1
- Status last verified
- Jan 2023
- First submitted
- 17 Nov 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38295131
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane in Case of a Laterally Deviated Larynx
- ClinicalTrials.gov ID
- NCT05679128
- Acronym / sponsor ID
- Devtrach1
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 10 Jan 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 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 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 arandomised to use either "palpation" or to use "ultrasonography" to DIAGNOSE the position of the cricothyroid membrane
| Arm | Type | Receives |
|---|---|---|
| palpation | Active comparator | Diagnostic Test: identification of the cricothyroid membrane using Palpationdigital palpation used to identify the cricothyroid membrane |
| ultrasonography | Experimental | Diagnostic Test: Identification of the cricothyroid membrane using ultrasonographyUltrasonography used to identify the cricothyroid membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants in a course of airway management
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| identification of the cricothyroid membrane using Palpationidentification of the cricothyroid using PALPATION, a procedure used to prepare for front of neck airway access | Diagnostic test | palpation |
| Identification of the cricothyroid membrane using ultrasonographyidentification of the cricothyroid membrane, using ULTRASONOGRAPHY, 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 identifications of the location of the cricothyroid membrane made by the participants, that is actually correct. ie the succesrate of correct identification.
1 secondary outcome
Time taken to identification of the estimated location of the cricothyroid membrane.
Time frame: up to 3 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 38295131Lohse 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing identification of the cricothyroid membrane using Palpation and Identification of the cricothyroid membrane using ultrasonography in people with Airway Management, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
On the ClinicalTrials.gov record for NCT05679128, which also lists 1 linked publication.
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 10 Jan 2023.