Circulatory FailureECHOBEDSIDENCT02974790
Diagnostic Performance of Echocardiography Performed by Emergency Physicians After a Basic Training
An observational study of Circulatory Failure and Echocardiography, run by University Hospital, Limoges at 1 site in France.
Trial summary
After a basic training to echocardiography, emergency physicians will have to answer simple clinical questions about circulatory failure mechanisms. The objective of the study is to assess the agreement between these answers and those of the expert physician in patients admitted in the emergency department with a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulatory Failure, Echocardiography
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2017to 2 Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemodynamic assessment will target patients with circulatory failure and / or sepsis in emergency unit
Who may be able to join
- patients > 18 years old
- patients admitted in the Emergency Department of Limoges University Hospital
- patients with circulatory failure defined as 1 or more of the following criteria :
- clinical signs of tissue hypoperfusion
- mottling
- Encephalopathy
Show all 16Show fewer
- Oliguria < 0.5 ml/kg/h
- biological signs of hypoperfusion
- Lactate > 2 mmol/L
- AND/OR Low blood pressure defined as a sBP < 90 mmHg or mBP < 65 mmHG or decrease of sBP > 40 mmHg compared with usual blood pressure
- OR Patients with signs of sepsis recently defined as the following :
- Suspicion of clinical infection
- At least 2 of the 3 following items (i.e. SOFA > 2 points with 1 point/item) :
- Glasgow score < 13
- Respiratory rate > 22 cycle/min
- Systolic blood pressure < 100 mmHg
Who cannot join
- Pregnant patients
- Moribund patients or with limited care
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
After a basic training to echocardiography, emergency physicians will have to answer simple clinical questions about circulatory failure mechanisms. The objective of the study is to assess the agreement between these answers and those of the expert physician in patients admitted in the emergency department with a circulatory failure due to sepsis or not. Emergency physicians will volunteer to take part in a basic training on echocardiography. The training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the different views and to identify the anatomical structures. The second part of the study will start after the training. Each eligible patient will be successively assessed by two investigators: one emergency physician recently trained and the expert physician. The echocardiography will be performed as soon as possible in the emergency department before or after the initiation of treatment without delaying it. The order of hemodynamic assessments will be random depending on the availability of the investigators; both assessments will however be performed within 30 minutes. Each investigator will independently read the echocardiography in real time at patients' bedside. They will then answer a limited list of standardized questions using two-choice answers or predefined choices. Finally investigators will choose a therapeutic proposition among a predefined list based on the answers. Only the results of the echocardiography performed by the expert physician will be used in patient management.
Read the detailed description
After a basic training to echocardiography, emergency physicians will have to answer simple clinical questions about circulatory failure mechanisms. The objective of the study is to assess the agreement between these answers and those of the expert physician in patients admitted in the emergency department with a circulatory failure due to sepsis or not. Emergency physicians will volunteer to take part in a basic training on echocardiography. The training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the different views and to identify the anatomical structures. The second part of the study will start after the training. Each eligible patient will be successively assessed by two investigators: one emergency physician recently trained and the expert physician. The echocardiography will be performed as soon as possible in the emergency department before or after the initiation of treatment without delaying it. The order of hemodynamic assessments will be random depending on the availability of the investigators; both assessments will however be performed within 30 minutes. Each investigator will independently read the echocardiography in real time at patients' bedside. They will then answer a limited list of standardized questions using two-choice answers or predefined choices. Finally investigators will choose a therapeutic proposition among a predefined list based on the answers. Only the results of the echocardiography performed by the expert physician will be used in patient management.
- Conditions
- Circulatory Failure, Echocardiography
- Being tested
- Echocardiography
- Keywords
- echocardiography, training, emergency department, circulatory failure
- Medical subject headings
- Shock, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyProcedure or surgery
Two-dimensional imaging echocardiography
| Study group | Role | What they receive |
|---|---|---|
| Circulatory failure | Patients with a circulatory failure due to a sepsis or not Receives: Procedure: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between emergency physician and referee physician echocardiography
Agreement between the measurements performed using two-dimensional imaging echocardiography by an emergency physician and the referring physician according to the following data :
- size of the left ventricle
- systolic function of the left ventricle
- size of the right ventricle
- dysfunction of the right ventricle
- size of the inferior vena cava pericardial effusion
Measured: Day 1
Secondary outcomes (1)
Agreement between emergency physicians and referring physician therapeutic propositions
Agreement between emergency physicians and referring physician therapeutic propositions according to the following choices:
- vascular filling define as a water volume of at least 500 mL
- vasopressor support
- positive inotropic therapy
- salt and water depletion
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study start2 Jan 2017
- Primary completion2 Jan 2018
- Study completion2 Mar 2018
Why it stopped: Not enough patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974790
- Sponsor's protocol ID
- I16035 (ECHOBEDSIDE)
- Acronym
- ECHOBEDSIDE
- Status last verified
- Mar 2018
- First submitted
- 23 Nov 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of Echocardiography Performed by Emergency Physicians After a Basic Training
- ClinicalTrials.gov ID
- NCT02974790
- Acronym / sponsor ID
- ECHOBEDSIDE / I16035 (ECHOBEDSIDE)
- Conditions
- Circulatory Failure, Echocardiography
- Keywords
- echocardiography, training, emergency department, circulatory failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough patient
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- University Hospital, Tours
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 28 Nov 2016 (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.
After a basic training to echocardiography, emergency physicians will have to answer simple clinical questions about circulatory failure mechanisms. The objective of the study is to assess the agreement between these answers and those of the expert physician in patients admitted in the emergency department with a circulatory failure due to sepsis or not. Emergency physicians will volunteer to take part in a basic training on echocardiography. The training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the different views and to identify the anatomical structures. The second part of the study will start after the training. Each eligible patient will be successively assessed by two investigators: one emergency physician recently trained and the expert physician. The echocardiography will be performed as soon as possible in the emergency department before or after the initiation of treatment without delaying it. The order of hemodynamic assessments will be random depending on the availability of the investigators; both assessments will however be performed within 30 minutes. Each investigator will independently read the echocardiography in real time at patients' bedside. They will then answer a limited list of standardized questions using two-choice answers or predefined choices. Finally investigators will choose a therapeutic proposition among a predefined list based on the answers. Only the results of the echocardiography performed by the expert physician will be used in patient management.
Detailed description
After a basic training to echocardiography, emergency physicians will have to answer simple clinical questions about circulatory failure mechanisms. The objective of the study is to assess the agreement between these answers and those of the expert physician in patients admitted in the emergency department with a circulatory failure due to sepsis or not. Emergency physicians will volunteer to take part in a basic training on echocardiography. The training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the different views and to identify the anatomical structures. The second part of the study will start after the training. Each eligible patient will be successively assessed by two investigators: one emergency physician recently trained and the expert physician. The echocardiography will be performed as soon as possible in the emergency department before or after the initiation of treatment without delaying it. The order of hemodynamic assessments will be random depending on the availability of the investigators; both assessments will however be performed within 30 minutes. Each investigator will independently read the echocardiography in real time at patients' bedside. They will then answer a limited list of standardized questions using two-choice answers or predefined choices. Finally investigators will choose a therapeutic proposition among a predefined list based on the answers. Only the results of the echocardiography performed by the expert physician will be used in patient management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Circulatory failure | – | Procedure: EchocardiographyPatients with a circulatory failure due to a sepsis or not |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodynamic assessment will target patients with circulatory failure and / or sepsis in emergency unit
Key inclusion criteria (16 listed)
- patients > 18 years old
- patients admitted in the Emergency Department of Limoges University Hospital
- patients with circulatory failure defined as 1 or more of the following criteria :
- clinical signs of tissue hypoperfusion
- mottling
Key exclusion criteria (3 listed)
- Pregnant patients
- Moribund patients or with limited care
- Patients under legal protection
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 |
|---|---|---|
| EchocardiographyTwo-dimensional imaging echocardiography | Procedure or surgery | Circulatory failure |
Primary outcome
Agreement between emergency physician and referee physician echocardiography
Time frame: Day 1
Agreement between the measurements performed using two-dimensional imaging echocardiography by an emergency physician and the referring physician according to the following data : * size of the left ventricle * systolic function of the left ventricle * size of the right ventricle * dysfunction of the right ventricle * size of the inferior vena cava pericardial effusion
1 secondary outcome
Agreement between emergency physicians and referring physician therapeutic propositions
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Not enough patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- 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.
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 Circulatory Failure and Echocardiography, run by University Hospital, Limoges at 1 site in France.
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 16 inclusion and 3 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 29 Mar 2018. 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 France. 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: Not enough patient). 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?
Agreement between emergency physician and referee physician echocardiography (time frame: Day 1). 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 29 Mar 2018.