Focus: Localizing the Cricothyroid Membrane Before Airway ManagementNCT01735760
Ultrasound Examination Versus Palpation to Locate the Cricothyroid Membrane
An observational study of Focus: Localizing the Cricothyroid Membrane Before Airway Management, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Anesthesiologists get a course on localizing the cricothyroid membrane on a human using ultrasonography. Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Focus: Localizing the Cricothyroid Membrane Before Airway Management
- How many people
- 44 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Dec 2012
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: anesthesiologists
Who may be able to join
- being an anesthesiologist attending our airway management course
Who cannot join
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound Examination and Palpation to Locate the Cricothyroid Membrane - a Randomized Study
Anesthesiologists get a course on localizing the cricothyroid membrane on a human using ultrasonography. Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.
Read the detailed description
The ability to localize the cricothyroid membrane on patients before airway management is crucial in order to be able to follow the difficult airway algorithms.
Studies have show a high failure rate when anesthesiologists rely on palpation.
In this study Anesthesiologists get an e-learning course, get literature to study , and get a theoretical course and a hands-on course in using ultrasound for localizing the cricothyroid membrane. . Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.
- Keywords
- airway management, cricothyroid membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Palpation | The group using palpation as primary attempt at localizing the cricothyroid membrane | |
| Ultrasonography | The group using ultrasound for their primary approach to localizing the cricothyroid membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of success of localizing the cricothyroid membrane with ultrasound and palpation
the rate of success is measured
Measured: december 2012
Secondary outcomes (1)
time to localise the cricothyroid membrane with ultrasonography and palpation
time measure for both ultrasonographic and palpation method
Measured: december 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus: Localizing the Cricothyroid Membrane Before 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 44 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
- NCT01735760
- Sponsor's protocol ID
- US-MC-001
- Status last verified
- Nov 2013
- First submitted
- 24 Nov 2012
- Last updated
- 26 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Examination and Palpation to Locate the Cricothyroid Membrane - a Randomized Study
- ClinicalTrials.gov ID
- NCT01735760
- Acronym / sponsor ID
- US-MC-001
- Keywords
- airway management, cricothyroid membrane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Nov 2012 (estimated)
- 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.
Anesthesiologists get a course on localizing the cricothyroid membrane on a human using ultrasonography. Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.
Detailed description
The ability to localize the cricothyroid membrane on patients before airway management is crucial in order to be able to follow the difficult airway algorithms.
Studies have show a high failure rate when anesthesiologists rely on palpation.
In this study Anesthesiologists get an e-learning course, get literature to study , and get a theoretical course and a hands-on course in using ultrasound for localizing the cricothyroid membrane. . Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palpation | – | –The group using palpation as primary attempt at localizing the cricothyroid membrane |
| Ultrasonography | – | –The group using ultrasound for their primary approach to localizing the cricothyroid membrane |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- anesthesiologists
Key inclusion criteria (1 listed)
- being an anesthesiologist attending our airway management course
Key exclusion criteria (1 listed)
- unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
rate of success of localizing the cricothyroid membrane with ultrasound and palpation
Time frame: december 2012
the rate of success is measured
1 secondary outcome
time to localise the cricothyroid membrane with ultrasonography and palpation
Time frame: december 2012
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focus: Localizing the Cricothyroid Membrane Before 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?
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: finished, as of the sponsor's last update on 26 Nov 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
rate of success of localizing the cricothyroid membrane with ultrasound and palpation (time frame: december 2012). 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 26 Nov 2013.