UltrasonographyNCT02304133
Transfer From a Point-of-care Ultrasound Course
A study testing Education in people with Ultrasonography, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
This study explores the effect of a four-hour ultrasound course on physicians' point-of-care ultrasound performance on patients representing acute abdominal surgical conditions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography
- What is being tested?
- Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Nov 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical Doctor
- Signed up for a courses in abdominal point-of-care ultrasound
Who cannot join
- None
About this study
Official title: Transfer From a Point-of-care Ultrasound Course to Diagnostic Performance on Patients - a Randomized Controlled Trial
This study explores the effect of a four-hour ultrasound course on physicians' point-of-care ultrasound performance on patients representing acute abdominal surgical conditions.
Read the detailed description
A randomized controlled trial with physicians was conducted. The intervention group participated in a four-hour abdominal POC US course before performing ultrasound on four patients with different abdominal surgical conditions. The control group did not participate in a course before performing ultrasound on the patients.
- Conditions
- Ultrasonography
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | participating in a four-hour course in abdominal POC US Receives: Other: Education |
| Control | Placebo comparator | no training Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound performance
An Objective Structured Assessment of Ultrasound Skills (OSAUS) scoring form was used to assess ultrasound performance
Measured: 4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances
Diagnostic accuracy
The ultrasound diagnoses were evaluated as "correct," "inconclusive," or "false," and the diagnostic accuracy was calculated by sensitivity and specificity
Measured: 4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionNov 2014
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 UltrasonographyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Todsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304133
- Sponsor's protocol ID
- H-3-2012-006
- Status last verified
- Nov 2014
- First submitted
- 24 Nov 2014
- Last updated
- 1 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Todsen T, Jensen ML, Tolsgaard MG, Olsen BH, Henriksen BM, Hillingso JG, Konge L, Ringsted C. Transfer from point-of-care Ultrasonography training to diagnostic performance on patients--a randomized controlled trial. Am J Surg. 2016 Jan;211(1):40-5. doi: 10.1016/j.amjsurg.2015.05.025. Epub 2015 Jul 31.
PubMed 26323998
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer From a Point-of-care Ultrasound Course to Diagnostic Performance on Patients - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02304133
- Acronym / sponsor ID
- H-3-2012-006
- Conditions
- Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 1 Dec 2014 (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.
This study explores the effect of a four-hour ultrasound course on physicians' point-of-care ultrasound performance on patients representing acute abdominal surgical conditions.
Detailed description
A randomized controlled trial with physicians was conducted. The intervention group participated in a four-hour abdominal POC US course before performing ultrasound on four patients with different abdominal surgical conditions. The control group did not participate in a course before performing ultrasound on the patients.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Educationparticipating in a four-hour course in abdominal POC US |
| Control | Placebo comparator | Other: Educationno training |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Medical Doctor
- Signed up for a courses in abdominal point-of-care ultrasound
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Education | Other | Control, Intervention |
Primary outcome
Ultrasound performance
Time frame: 4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances
An Objective Structured Assessment of Ultrasound Skills (OSAUS) scoring form was used to assess ultrasound performance
Diagnostic accuracy
Time frame: 4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances
The ultrasound diagnoses were evaluated as "correct," "inconclusive," or "false," and the diagnostic accuracy was calculated by sensitivity and specificity
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 1 Dec 2014.
- Derived from this study: PubMed 26323998Todsen T, Jensen ML, Tolsgaard MG, Olsen BH, Henriksen BM, Hillingso JG, Konge L, Ringsted C. Transfer from point-of-care Ultrasonography training to diagnostic performance on patients--a randomized controlled trial. Am J Surg. 2016 Jan;211(1):40-5. doi: 10.1016/j.amjsurg.2015.05.025. Epub 2015 Jul 31.
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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 Education in people with Ultrasonography, 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 2 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 1 Dec 2014. 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. Some participants in this study may receive a placebo. 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?
Ultrasound performance (time frame: 4 ultrasound cases conducted by the study participants were assessed immediately after the intervention/control circumstances). The study lists 2 primary outcomes in all. 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 NCT02304133, 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 1 Dec 2014.