DyspneaMETUSNCT03214809
The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams
A study testing ultrasound protocol in people with Dyspnea and Coma, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams (MET) Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dyspnea, Coma, Hypotension and Shock
- What is being tested?
- ultrasound protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jan 2019to 11 May 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients on the general wards in need of treatment by the MET team.
Who cannot join
- age (<18 years),
- pregnancy:
Trial locations and contacts
1 site in 1 country.
About this study
Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams (MET)
Read the detailed description
Rationale: Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams Objective: Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied. Also other secondary endpoints will be evaluated.
Study design prospective, interventional study Study population: patients on the general wards in need treatment by the MET team Intervention (if applicable): When the MET team arrives first assessment will be done according to the abcde algorithm. If immediate interventions are needed (intubation, CPR etc) this will be done first (and noted). After the abcde assessment an initial diagnosis is noted. In the even weeks the thoracic ultrasound protocol will be done, in the uneven weeks not. After the use of ultrasound various variables are noted.
Main study parameters/endpoints:
Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied.
Also other secondary endpoints will be evaluated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The use of ultrasound is without direct side effects in terms of radiation or other potential (non)physical disturbances.
There are no data on the effects of the use of ultrasound during MET calls. The MET team will first deliver acute care if necessary, the ultrasound protocol can be done within 10-15 minutes which is acceptable in terms of MET call care. The MET team physician can at any point decide to use the ultrasound if he/she thinks it is necessary.
In other circumstances (e.g. emergency department or intensive care units) point-of-care ultrasound is considered to be part of standard care.
The investigators will study the potential influence of ultrasound during MET calls in terms of accuracy of the initial diagnosis and whether ultrasound influences initial treatment, patients' disposition and so on, ultrasound is no treatment nor will be the use of ultrasound be decisive in the treatment of MET call patients in this study.
- Conditions
- Dyspnea, Coma, Hypotension and Shock
- Being tested
- ultrasound protocol
- Keywords
- ultrasound, MET team, Concordance
- Medical subject headings
- Dyspnea, Coma, Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound protocolDiagnostic test
after first assessment and treatment by the MET team, an Multi-organ ultrasound protocol will be run by the MET doctor
| Study group | Role | What they receive |
|---|---|---|
| Thoracic ultrasound protocol | Experimental | ABCDE algorithm with Thoracic ultrasound protocol Receives: Diagnostic Test: ultrasound protocol |
| No Thoracic ultrasound protocol | No intervention | ABCDE algorithm without Thoracic ultrasound protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied
final diagnosis will be determined by 2 independent experts on the basis of chart review and will be compared with the MET team diagnosis. There are 8 pre defined diagnosis categories. The difference in concordance between the MET diagnosis with and without the use of ultrasound with the definitive diagnosis will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
Measured: after 2-3 weeks
Secondary outcomes (8)
Possible difference in diagnostic certainty
diagnostic certainty is measured on a scale 0-10. - Descriptive statistics will be presented as mean with standard deviation for normally distributed continuous data, median and inter-quartile range for skewed continuous variables. Differences between groups will be tested using the Students' T-test. In case of unevenly distributed variables, differences between groups will be tested using the Mann Whitney U Test.
Measured: direct after inclusion
Possible differences in initial treatment
There are 11 pre-defined therapy categories. - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
Measured: direct after inclusion
Possible differences in patients' disposition
There are 4 pre-defined categories in patients' disposition. - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
Measured: direct after inclusion
Whether the use of ultrasound was considered to be helpful
The answer to this question is binary (yes or no). - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
Measured: direct after inclusion
MET physicians characteristics
there are 5 pre-defined categories in MET physician characteristics. - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
Measured: direct after inclusion
Possible difference in the time needed to reach a diagnosis
time in minutes. - Descriptive statistics will be presented as mean with standard deviation for normally distributed continuous data, median and inter-quartile range for skewed continuous variables. Differences between groups will be tested using the Students' T-test. In case of unevenly distributed variables, differences between groups will be tested using the Mann Whitney U Test.
Measured: direct after inclusion
Possible difference in the need for supervisor attendance
the answer to this question is binary (yes or no). - Descriptive statistics will be presented as numbers and percentages for dichotomous and categorical variables. Differences between groups will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
Measured: direct after inclusion
Number of times ultrasound was used in te "non-ultrasound weeks"
answer to this question is a number. - Descriptive statistics will be presented as mean with standard deviation for normally distributed continuous data, median and inter-quartile range for skewed continuous variables. Differences between groups will be tested using the Students' T-test. In case of unevenly distributed variables, differences between groups will be tested using the Mann Whitney U Test
Measured: direct after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start18 Jan 2019
- Primary completion11 May 2020
- Study completion11 May 2020
Why it stopped: Slow inclusion rate (partly due to Covid-19)
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 DyspneaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- When the MET team arrives first assessment will be done according to the abcde algorithm. If immediate interventions are needed (intubation, CPR etc) this will be done first (and noted). After the abcde assessment an initial diagnosis is noted. In the even weeks the thoracic ultrasound protocol will be done, in the uneven weeks not. After the use of ultrasound various variables are noted.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Blans, MD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214809
- Sponsor's protocol ID
- NL61884.091.17
- Acronym
- METUS
- Status last verified
- Jul 2020
- First submitted
- 19 Jun 2017
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blans MJ, Bousie E, van der Hoeven JG, Bosch FH. A point-of-care thoracic ultrasound protocol for hospital medical emergency teams (METUS) improves diagnostic accuracy. Ultrasound J. 2021 Jun 4;13(1):29. doi: 10.1186/s13089-021-00229-3.
PubMed 34089087
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Point-of-care Thoracic Ultrasound Protocol for Hospital Medical Emergency Teams
- ClinicalTrials.gov ID
- NCT03214809
- Acronym / sponsor ID
- METUS / NL61884.091.17
- Conditions
- Dyspnea, Coma, Hypotension and Shock
- Keywords
- ultrasound, MET team, Concordance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow inclusion rate (partly due to Covid-19)
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 12 Jul 2017 (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.
Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams (MET)
Detailed description
Rationale: Study to assess the possible effects of the use of a point-of-care thoracic ultrasound protocol for hospital medical emergency teams Objective: Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied. Also other secondary endpoints will be evaluated.
Study design prospective, interventional study Study population: patients on the general wards in need treatment by the MET team Intervention (if applicable): When the MET team arrives first assessment will be done according to the abcde algorithm. If immediate interventions are needed (intubation, CPR etc) this will be done first (and noted). After the abcde assessment an initial diagnosis is noted. In the even weeks the thoracic ultrasound protocol will be done, in the uneven weeks not. After the use of ultrasound various variables are noted.
Main study parameters/endpoints:
Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied.
Also other secondary endpoints will be evaluated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The use of ultrasound is without direct side effects in terms of radiation or other potential (non)physical disturbances.
There are no data on the effects of the use of ultrasound during MET calls. The MET team will first deliver acute care if necessary, the ultrasound protocol can be done within 10-15 minutes which is acceptable in terms of MET call care. The MET team physician can at any point decide to use the ultrasound if he/she thinks it is necessary.
In other circumstances (e.g. emergency department or intensive care units) point-of-care ultrasound is considered to be part of standard care.
The investigators will study the potential influence of ultrasound during MET calls in terms of accuracy of the initial diagnosis and whether ultrasound influences initial treatment, patients' disposition and so on, ultrasound is no treatment nor will be the use of ultrasound be decisive in the treatment of MET call patients in this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- When the MET team arrives first assessment will be done according to the abcde algorithm. If immediate interventions are needed (intubation, CPR etc) this will be done first (and noted). After the abcde assessment an initial diagnosis is noted. In the even weeks the thoracic ultrasound protocol will be done, in the uneven weeks not. After the use of ultrasound various variables are noted.
| Arm | Type | Receives |
|---|---|---|
| Thoracic ultrasound protocol | Experimental | Diagnostic Test: ultrasound protocolABCDE algorithm with Thoracic ultrasound protocol |
| No Thoracic ultrasound protocol | No intervention | –ABCDE algorithm without Thoracic ultrasound protocol |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients on the general wards in need of treatment by the MET team.
Key exclusion criteria (2 listed)
- age (<18 years),
- pregnancy:
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 |
|---|---|---|
| ultrasound protocolafter first assessment and treatment by the MET team, an Multi-organ ultrasound protocol will be run by the MET doctor | Diagnostic test | Thoracic ultrasound protocol |
Primary outcome
Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied
Time frame: after 2-3 weeks
final diagnosis will be determined by 2 independent experts on the basis of chart review and will be compared with the MET team diagnosis. There are 8 pre defined diagnosis categories. The difference in concordance between the MET diagnosis with and without the use of ultrasound with the definitive diagnosis will be tested with a chi-square or a Fisher Exact test in case of small expected frequencies.
8 secondary outcomes
Possible difference in diagnostic certainty
Time frame: direct after inclusion
Possible differences in initial treatment
Time frame: direct after inclusion
Possible differences in patients' disposition
Time frame: direct after inclusion
Whether the use of ultrasound was considered to be helpful
Time frame: direct after inclusion
MET physicians characteristics
Time frame: direct after inclusion
Possible difference in the time needed to reach a diagnosis
Time frame: direct after inclusion
Possible difference in the need for supervisor attendance
Time frame: direct after inclusion
Number of times ultrasound was used in te "non-ultrasound weeks"
Time frame: direct after inclusion
Results and safety
The study was stopped early (reason given: Slow inclusion rate (partly due to Covid-19)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Derived from this study: PubMed 34089087Blans MJ, Bousie E, van der Hoeven JG, Bosch FH. A point-of-care thoracic ultrasound protocol for hospital medical emergency teams (METUS) improves diagnostic accuracy. Ultrasound J. 2021 Jun 4;13(1):29. doi: 10.1186/s13089-021-00229-3.
- Individual participant dataSharing planned: No
Related trials for Dyspnea
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea
Dyspnea
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 Blans, MD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound protocol in people with Dyspnea and Coma, run by Rijnstate Hospital at 1 site in Netherlands.
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 2 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: stopped early, as of the sponsor's last update on 20 Jul 2020. 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 Netherlands. 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 was stopped early (reason given: Slow inclusion rate (partly due to Covid-19)). 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?
Concordance between MET diagnosis with and without the use of ultrasound with the chart review definitive diagnosis will be studied (time frame: after 2-3 weeks). 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 NCT03214809, 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 20 Jul 2020.