Coronary Artery DiseasePreDeARMNCT02678559
Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
A study testing tee measurement, flotrac measurement and clearsight measurement in people with Coronary Artery Disease and Coronary Artery Bypass, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass, Hypovolemia
- What is being tested?
- tee measurement, flotrac measurement and clearsight measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient Undergoing a surgical procedure of coronary artery bypass, with cardiopulmonary bypass Written consent collected
Who cannot join
- Emergency case
- Pericardial effusion
- Aortic or mitral valvulopathy
- Contraindication for : TEE, alveolar recruitment manoeuvre (emphysema, pneumothorax, hemodynamic instability), Ringer Lactate solution infusion
- Bad echogenicity
- Patient refusal to participate to the study
- No health insurance
Trial locations and contacts
1 site in 1 country.
About this study
The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.
Read the detailed description
Population studied: anesthetized patients for cardiac surgery of coronary bypass.
Secondary endpoints : - comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. These mini-invasive systems are : Clearsight system (Edwards Lifescience) and Flotrac system (Edwards Lifescience)
- Difference between pre and post-cardiopulmonary bypass status on principal purpose evaluation
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass, Hypovolemia, Anesthesia, General, Pulmonary Atelectasis
- Being tested
- tee measurement, flotrac measurement, clearsight measurement
- Keywords
- Alveolar recruitment manoeuvre, Lung recruitment, Preload dependency, Cardiac surgery, Transoesophageal echocardiography
- Medical subject headings
- Coronary Artery Disease, Hypovolemia, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tee measurementOther
flotrac measurementOther
clearsight measurementOther
| Study group | Role | What they receive |
|---|---|---|
| TEE monitory system | Experimental | comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. Receives: Other: tee measurement; Other: flotrac measurement; Other: clearsight measurement |
| mini-invasive monitoring system | Experimental | comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. Receives: Other: tee measurement; Other: flotrac measurement; Other: clearsight measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of stroke volume
Variation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery
Measured: at the beginning of cardiac surgery
Secondary outcomes (66)
Velocity time integral (cm)
Velocity time integral (cm) (TEE measurement)
Measured: at the begining of cardiac surgery
Velocity time integral (cm)
Velocity time integral (cm) (TEE measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Velocity time integral (cm)
Velocity time integral (cm) (TEE measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Cardiac index (l/min/m2)
Cardiac index (l/min/m2) (TEE measurement)
Measured: at the begining of cardiac surgery
Cardiac index (l/min/m2)
Cardiac index (l/min/m2) (TEE measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Cardiac index (l/min/m2)
Cardiac index (l/min/m2) (TEE measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Right ventricle diameter/left ventricle diameter ratio
Right ventricle diameter/left ventricle diameter ratio (TEE measurement),
Measured: at the begining of cardiac surgery
Right ventricle diameter/left ventricle diameter ratio
Right ventricle diameter/left ventricle diameter ratio (TEE measurement),
Measured: After fluid challenges until patient is on a preload independency state.
Right ventricle diameter/left ventricle diameter ratio
Right ventricle diameter/left ventricle diameter ratio (TEE measurement),
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
E/A ratio
E/A ratio (TEE measurement)
Measured: at the begining of cardiac surgery
E/A ratio
E/A ratio (TEE measurement)
Measured: After fluid challenges until patient is on a preload independency state.
E/A ratio
E/A ratio (TEE measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Sus-hepatic vein Doppler profile
Sus-hepatic vein Doppler profile (TEE measurement)
Measured: at the begining of cardiac surgery
Sus-hepatic vein Doppler profile
Sus-hepatic vein Doppler profile (TEE measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Sus-hepatic vein Doppler profile
Sus-hepatic vein Doppler profile (TEE measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Invasive arterial pressure (mmHg)
Measured: at the begining of cardiac surgery
Invasive arterial pressure (mmHg)
Measured: After fluid challenges until patient is on a preload independency state.
Invasive arterial pressure (mmHg)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Heart rate (pulse/min)
Measured: at the begining of cardiac surgery
Heart rate (pulse/min)
Measured: After fluid challenges until patient is on a preload independency state.
Heart rate (pulse/min)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Expired CO2 (mmHg)
Measured: at the begining of cardiac surgery
Expired CO2 (mmHg)
Measured: After fluid challenges until patient is on a preload independency state.
Expired CO2 (mmHg)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Central venous pressure (mmHg)
Measured: at the begining of cardiac surgery
Central venous pressure (mmHg)
Measured: After fluid challenges until patient is on a preload independency state.
Central venous pressure (mmHg)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Pulse pressure variation (%)
Measured: at the begining of cardiac surgery
Pulse pressure variation (%)
Measured: After fluid challenges until patient is on a preload independency state.
Pulse pressure variation (%)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Perfusion index (pulsoxymeter)
Measured: at the begining of cardiac surgery
Perfusion index (pulsoxymeter)
Measured: After fluid challenges until patient is on a preload independency state.
Perfusion index (pulsoxymeter)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume (ml) (Flotrac measurement)
Measured: at the begining of cardiac surgery
Stroke volume (ml) (Flotrac measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Stroke volume (ml) (Flotrac measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume variation (%) (Flotrac measurement)
Measured: at the begining of cardiac surgery
Stroke volume variation (%) (Flotrac measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Stroke volume variation (%) (Flotrac measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Cardiac index (l/min/m2) (Flotrac measurement)
Measured: at the begining of cardiac surgery
Cardiac index (l/min/m2) (Flotrac measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Cardiac index (l/min/m2) (Flotrac measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Pulse pressure variation (%) (Flotrac measurement)
Measured: at the begining of cardiac surgery
Pulse pressure variation (%) (Flotrac measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Pulse pressure variation (%) (Flotrac measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Arterial pressure (mmHg) (Flotrac measurement)
Measured: at the begining of cardiac surgery
Arterial pressure (mmHg) (Flotrac measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Arterial pressure (mmHg) (Flotrac measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume (ml) (Clearsight measurement)
Measured: at the begining of cardiac surgery
Stroke volume (ml) (Clearsight measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Stroke volume (ml) (Clearsight measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume variation (%) (Clearsight measurement)
Measured: at the begining of cardiac surgery
Stroke volume variation (%) (Clearsight measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Stroke volume variation (%) (Clearsight measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Cardiac index (l/min/m2) (Clearsight measurement)
Measured: at the begining of cardiac surgery
Cardiac index (l/min/m2) (Clearsight measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Cardiac index (l/min/m2) (Clearsight measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Pulse pressure variation (%) (Clearsight measurement)
Measured: at the begining of cardiac surgery
Pulse pressure variation (%) (Clearsight measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Pulse pressure variation (%) (Clearsight measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Arterial pressure (mmHg) (Clearsight measurement)
Measured: at the begining of cardiac surgery
Arterial pressure (mmHg) (Clearsight measurement)
Measured: After fluid challenges until patient is on a preload independency state.
Arterial pressure (mmHg) (Clearsight measurement)
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Near infrared spectroscopy : Cerebral SrO2
Measured: at the begining of cardiac surgery
Near infrared spectroscopy : Cerebral SrO2
Measured: After fluid challenges until patient is on a preload independency state.
Near infrared spectroscopy : Cerebral SrO2
Measured: After the cardiopulmonary bypass period, when sternotomy will be closed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678559
- Sponsor's protocol ID
- CHU-0254
- Acronym
- PreDeARM
- Status last verified
- Apr 2017
- First submitted
- 15 Jan 2016
- Last updated
- 20 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres
- ClinicalTrials.gov ID
- NCT02678559
- Acronym / sponsor ID
- PreDeARM / CHU-0254
- Conditions
- Coronary Artery Disease, Coronary Artery Bypass, Hypovolemia, Anesthesia, General, Pulmonary Atelectasis
- Keywords
- Alveolar recruitment manoeuvre, Lung recruitment, Preload dependency, Cardiac surgery, Transoesophageal echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Feb 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.
The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.
Detailed description
Population studied: anesthetized patients for cardiac surgery of coronary bypass.
Secondary endpoints : - comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. These mini-invasive systems are : Clearsight system (Edwards Lifescience) and Flotrac system (Edwards Lifescience)
- Difference between pre and post-cardiopulmonary bypass status on principal purpose evaluation
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEE monitory system | Experimental | Other: tee measurement, Other: flotrac measurement, Other: clearsight measurementcomparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. |
| mini-invasive monitoring system | Experimental | Other: tee measurement, Other: flotrac measurement, Other: clearsight measurementcomparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient Undergoing a surgical procedure of coronary artery bypass, with cardiopulmonary bypass Written consent collected
Key exclusion criteria (7 listed)
- Emergency case
- Pericardial effusion
- Aortic or mitral valvulopathy
- Contraindication for : TEE, alveolar recruitment manoeuvre (emphysema, pneumothorax, hemodynamic instability), Ringer Lactate solution infusion
- Bad echogenicity
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 |
|---|---|---|
| tee measurement | Other | TEE monitory system, mini-invasive monitoring system |
| flotrac measurement | Other | TEE monitory system, mini-invasive monitoring system |
| clearsight measurement | Other | TEE monitory system, mini-invasive monitoring system |
Primary outcome
Variation of stroke volume
Time frame: at the beginning of cardiac surgery
Variation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery
66 secondary outcomes
Velocity time integral (cm)
Time frame: at the begining of cardiac surgery
Velocity time integral (cm)
Time frame: After fluid challenges until patient is on a preload independency state.
Velocity time integral (cm)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Cardiac index (l/min/m2)
Time frame: at the begining of cardiac surgery
Cardiac index (l/min/m2)
Time frame: After fluid challenges until patient is on a preload independency state.
Cardiac index (l/min/m2)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Right ventricle diameter/left ventricle diameter ratio
Time frame: at the begining of cardiac surgery
Right ventricle diameter/left ventricle diameter ratio
Time frame: After fluid challenges until patient is on a preload independency state.
Right ventricle diameter/left ventricle diameter ratio
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
E/A ratio
Time frame: at the begining of cardiac surgery
E/A ratio
Time frame: After fluid challenges until patient is on a preload independency state.
E/A ratio
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Sus-hepatic vein Doppler profile
Time frame: at the begining of cardiac surgery
Sus-hepatic vein Doppler profile
Time frame: After fluid challenges until patient is on a preload independency state.
Sus-hepatic vein Doppler profile
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Invasive arterial pressure (mmHg)
Time frame: at the begining of cardiac surgery
Invasive arterial pressure (mmHg)
Time frame: After fluid challenges until patient is on a preload independency state.
Invasive arterial pressure (mmHg)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Heart rate (pulse/min)
Time frame: at the begining of cardiac surgery
Heart rate (pulse/min)
Time frame: After fluid challenges until patient is on a preload independency state.
Heart rate (pulse/min)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Expired CO2 (mmHg)
Time frame: at the begining of cardiac surgery
Expired CO2 (mmHg)
Time frame: After fluid challenges until patient is on a preload independency state.
Expired CO2 (mmHg)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Central venous pressure (mmHg)
Time frame: at the begining of cardiac surgery
Central venous pressure (mmHg)
Time frame: After fluid challenges until patient is on a preload independency state.
Central venous pressure (mmHg)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Pulse pressure variation (%)
Time frame: at the begining of cardiac surgery
Pulse pressure variation (%)
Time frame: After fluid challenges until patient is on a preload independency state.
Pulse pressure variation (%)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Perfusion index (pulsoxymeter)
Time frame: at the begining of cardiac surgery
Perfusion index (pulsoxymeter)
Time frame: After fluid challenges until patient is on a preload independency state.
Perfusion index (pulsoxymeter)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume (ml) (Flotrac measurement)
Time frame: at the begining of cardiac surgery
Stroke volume (ml) (Flotrac measurement)
Time frame: After fluid challenges until patient is on a preload independency state.
Stroke volume (ml) (Flotrac measurement)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Stroke volume variation (%) (Flotrac measurement)
Time frame: at the begining of cardiac surgery
Stroke volume variation (%) (Flotrac measurement)
Time frame: After fluid challenges until patient is on a preload independency state.
Stroke volume variation (%) (Flotrac measurement)
Time frame: After the cardiopulmonary bypass period, when sternotomy will be closed
Cardiac index (l/min/m2) (Flotrac measurement)
Time frame: at the begining of cardiac surgery
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 20 Apr 2017.
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
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?
A study testing tee measurement, flotrac measurement and clearsight measurement in people with Coronary Artery Disease and Coronary Artery Bypass, run by University Hospital, Clermont-Ferrand 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 1 inclusion and 7 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 20 Apr 2017. 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?
Variation of stroke volume (time frame: at the beginning of cardiac surgery). 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 20 Apr 2017.