Cardiac OutputReacshockNCT03937102
Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography
An observational study of Cardiac Output, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Physioflow® is a new device for measuring cardiac output in a non-invasive way using a thoracic bioimpedance technique. This technique has been validated in patients in stress tests as well as in Chronic Obstructive Pulmonary Disease (COPD) patients, in obese patients and in children. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Output
- What is being tested?
- cardiac output measure with TTE and cardiac output measure with Physioflow® thoracic electrical bioimpedance
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2019to 1 Apr 2020
- How long will I take part?
- 1 Day
- 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: Patient ≥18 year-old, sedated and adapted to the assisted controlled ventilation, receiving catecholamine (norepinephrine, epinephrine or dobutamine), requiring an haemodynamic evaluation by trans-thoracic echocardiography and PLR according to the attending physician.
Who may be able to join
- patient more than 18 year-old
- patient sedated and adapted to the assisted controlled ventilation
- patient receiving catecholamine (norepinephrine, epinephrine or dobutamine)
- patient requiring an haemodynamic evaluation by trans-thoracic echocardiography and PLR according to the attending physician
Who cannot join
- pregnant women
- patients with a poor echogenicity
- patients deprived of public law
Trial locations and contacts
1 site in 1 country.
About this study
Physioflow® is a new device for measuring cardiac output in a non-invasive way using a thoracic bioimpedance technique. This technique has been validated in patients in stress tests as well as in Chronic Obstructive Pulmonary Disease (COPD) patients, in obese patients and in children. Very little work has been published in intensive care unit (ICU) and no studies have been done on hemodynamically unstable patients. The aim of this work is to compare the cardiac output measured by Physioflow® to the transthoracic echocardiography (TTE) in ventilated, sedated patients hospitalized in ICU receiving catecholamines and for whom the attending physician wants to evaluate the fluid responsiveness using the TTE and a passive leg raising maneuver (PLR).
Read the detailed description
All patients included will be simultaneously monitored with TTE and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after PLR. If the attending physician decide to administer fluid expansion a new set of cardiac output measurement will be performed before and after the volume expansion.
- Conditions
- Cardiac Output
- Being tested
- cardiac output measure with TTE, cardiac output measure with Physioflow® thoracic electrical bioimpedance
- Keywords
- cardiac output, trans thoracic echocardiography, passive leg raising, volume expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac output measure with TTEProcedure or surgery
All patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR)
cardiac output measure with Physioflow® thoracic electrical bioimpedanceProcedure or surgery
All patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR)
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of cardiac output with transthoracic echocardiography (TTE) before PLR
Measure of Cardiac output with transthoracic echocardiography (TTE) before passive leg raising maneuver (PLR)
Measured: during one hour , the day of inclusion
Measure of Cardiac output with Physioflow before PLR
Measure of Cardiac output with Physioflow before passive leg raising maneuver (PLR)
Measured: during one hour , the day of inclusion
Measure of cardiac output with transthoracic echocardiography (TTE) after PLR
Measure of cardiac output with transthoracic echocardiography (TTE) after passive leg raising maneuver (PLR)
Measured: during one hour , the day of inclusion
Measure of cardiac output with Physioflow after PLR
Measure of cardiac output with Physioflow after passive leg raising maneuver (PLR)
Measured: during one hour , the day of inclusion
Secondary outcomes (2)
Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion
Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion
Measured: during one hour , the day of inclusion
Measure of cardiac output with Physioflow after volume expansion
Measure of cardiac output with Physioflow after volume expansion
Measured: during one hour , the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start25 Apr 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- 1 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Lens
- Responsible party
- Sponsor
- Investigators
- Didier Thevenin, MD, Principal investigator, Centre Hospitalier de Lens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937102
- Sponsor's protocol ID
- PI2018_843_0001
- Acronym
- Reacshock
- Status last verified
- Mar 2023
- First submitted
- 25 Apr 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Cardiac Output in Intensive Care Unit With Unstable Hemodynamic: Validation of Physioflow® Device Versus Trans Thoracic Echocardiography
- ClinicalTrials.gov ID
- NCT03937102
- Acronym / sponsor ID
- Reacshock / PI2018_843_0001
- Conditions
- Cardiac Output
- Keywords
- cardiac output, trans thoracic echocardiography, passive leg raising, volume expansion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Lens
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 3 May 2019 (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.
Physioflow® is a new device for measuring cardiac output in a non-invasive way using a thoracic bioimpedance technique. This technique has been validated in patients in stress tests as well as in Chronic Obstructive Pulmonary Disease (COPD) patients, in obese patients and in children. Very little work has been published in intensive care unit (ICU) and no studies have been done on hemodynamically unstable patients. The aim of this work is to compare the cardiac output measured by Physioflow® to the transthoracic echocardiography (TTE) in ventilated, sedated patients hospitalized in ICU receiving catecholamines and for whom the attending physician wants to evaluate the fluid responsiveness using the TTE and a passive leg raising maneuver (PLR).
Detailed description
All patients included will be simultaneously monitored with TTE and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after PLR. If the attending physician decide to administer fluid expansion a new set of cardiac output measurement will be performed before and after the volume expansion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient ≥18 year-old, sedated and adapted to the assisted controlled ventilation, receiving catecholamine (norepinephrine, epinephrine or dobutamine), requiring an haemodynamic evaluation by trans-thoracic echocardiography and PLR according to the attending physician.
Key inclusion criteria (4 listed)
- patient more than 18 year-old
- patient sedated and adapted to the assisted controlled ventilation
- patient receiving catecholamine (norepinephrine, epinephrine or dobutamine)
- patient requiring an haemodynamic evaluation by trans-thoracic echocardiography and PLR according to the attending physician
Key exclusion criteria (3 listed)
- pregnant women
- patients with a poor echogenicity
- patients deprived of public law
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 |
|---|---|---|
| cardiac output measure with TTEAll patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR) | Procedure or surgery | – |
| cardiac output measure with Physioflow® thoracic electrical bioimpedanceAll patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR) | Procedure or surgery | – |
Primary outcome
Measure of cardiac output with transthoracic echocardiography (TTE) before PLR
Time frame: during one hour , the day of inclusion
Measure of Cardiac output with transthoracic echocardiography (TTE) before passive leg raising maneuver (PLR)
Measure of Cardiac output with Physioflow before PLR
Time frame: during one hour , the day of inclusion
Measure of Cardiac output with Physioflow before passive leg raising maneuver (PLR)
Measure of cardiac output with transthoracic echocardiography (TTE) after PLR
Time frame: during one hour , the day of inclusion
Measure of cardiac output with transthoracic echocardiography (TTE) after passive leg raising maneuver (PLR)
Measure of cardiac output with Physioflow after PLR
Time frame: during one hour , the day of inclusion
Measure of cardiac output with Physioflow after passive leg raising maneuver (PLR)
2 secondary outcomes
Measure of cardiac output with transthoracic echocardiography (TTE) after volume expansion
Time frame: during one hour , the day of inclusion
Measure of cardiac output with Physioflow after volume expansion
Time frame: during one hour , the day of inclusion
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 22 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Cardiac Output
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
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RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Active, not recruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
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.
Didier Thevenin, MD principal investigator
Centre Hospitalier de Lens
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 Cardiac Output, run by Centre Hospitalier Universitaire, Amiens 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 4 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: finished, as of the sponsor's last update on 22 Mar 2023. 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 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?
Measure of cardiac output with transthoracic echocardiography (TTE) before PLR (time frame: during one hour , the day of inclusion). The study lists 4 primary outcomes in all. 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 22 Mar 2023.