Coronary Surgery With Cardiopulmonary BypassPhase 4ECOMIIINCT01535716
Effects of a Goal-directed Hemodynamic Therapy Driven by ECOM on Morbidity and Mortality After Cardiac Surgery?
A Phase 4 study testing hemodynamic optimization strategy driven by the ECOM and standard management strategy in people with Coronary Surgery With Cardiopulmonary Bypass, run by University Hospital, Caen at 1 site in France.
Trial summary
Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic optimizations are more efficient when based on the dynamic parameters than when based on the statics ones, and the major dynamic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Surgery With Cardiopulmonary Bypass
- What is being tested?
- hemodynamic optimization strategy driven by the ECOM and standard management strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Feb 2013
- Phase
- Phase 4
- 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
- Any man or woman
- Over 18 year-old
- After obtaining written informed consent
- Scheduled for elective coronary surgery with CPB
Who cannot join
- Emergency surgery (< 24h)
- Combined cardiac surgery
- Patients < 18 years-old and/or unable to give informed consent
- Patients who refuse to give informed consent
- Pregnancy
- PVC allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Goal-directed Hemodynamic Therapy Driven by Endotracheal Cardiac Output Monitoring System During Surgical Intervention Reduce Hospital Stay and Major Adverse Cardiac Events Following Cardiac Surgery?
Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic optimizations are more efficient when based on the dynamic parameters than when based on the statics ones, and the major dynamic criteria is the cardiac output. Unfortunately, transpulmonary thermodilution, the device considered as "The gold standard" to evaluate cardiac output is associated with many complications.Furthermore, devices commercialized in the past decade were not able to replace the transpulmonary thermodilution.
As all monitoring devices aren't reliable enough to be widely used in practice they are left aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on the analysis of several clinical parameters seems to guarantee good cares thanks to a favorable benefits/risks balance, it could be improved by new plug and play mini-invasive systems.
Read more
In the investigators opinion, the ECOM system seems able to provide a monitoring tool which responds to all the expectations of a modern hemodynamic monitoring device. It uses a well known technique, the bioimpedance. The investigators suppose this device should be more efficient than the one that has been used before. Indeed, as the system is build on the endotracheal tube, it comes closer to the aorta, where all the measures are made, and the recorded signal should be less affected by the passage through the surrounding tissues.
This randomized and controlled trial will study Patients scheduled for elective coronary surgery with cardiopulmonary bypass.
The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed hemodynamic therapy based on the ECOM cardiac output measure on mortality and major postoperative cardiac morbidity after coronary surgery, when compared with a standard management strategy.
Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard management strategy, applied to the control group, will be set and led by the attending anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and stroke volume variation.
The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure will reduce mortality and morbidity after cardiac surgery.
- Being tested
- hemodynamic optimization strategy driven by the ECOM, standard management strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodynamic optimization strategy driven by the ECOMBehavioural
Also called Endotracheal cardiac output monitoring
goal directed hemodynamic therapy is based on the ECOM evaluation of stroke volume variation (SVV) \& cardiac index (CI).
goals:
- SVV < 11%
- IC > 2,2 ml/min/m²
During the anesthesia
standard management strategyBehavioural
goal directed hemodynamic therapy will be set and performed by the attending anesthetist, based on the analysis of further clinical parameters: Standard monitoring : heart rate, saturation index
- Diuresis > 0,5ml/kg/h
- Blood pressure , PAM > 65 mmHg
- Pulse pressure variation
- CVP 8 to 12 cmH20
- Visual aspect of the heart
- Overload signs During the anesthesia
| Study group | Role | What they receive |
|---|---|---|
| ECOM group | Experimental | 50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass Receives: Behavioral: hemodynamic optimization strategy driven by the ECOM |
| standard management group | Active comparator | 50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass Receives: Behavioral: standard management strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
Measured: Data collected at the exit of hospital or at death, if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days. expected before 1 month
Secondary outcomes (4)
Number of major adverse cardiac events during stay in hospital
Measured: Data collected at the exit of ICU, at the exit of hospital or at death if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days.Up to 1 month
Length of stay in ICU
Measured: at the exit of ICU or at death, if during hospital stay.expected before 1 month
In-hospital mortality
Measured: at the end of the study. up to 12 month
Number of patients with Major adverse cardiac events during in-hospital stay.
Measured: at the end of the study. Up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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 Coronary Surgery With Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- CONMED Corporation
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Fellahi, Study director, EA3212: groupe coeur et ischémie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535716
- Sponsor's protocol ID
- 2011-A01210-41
- Acronym
- ECOMIII
- Status last verified
- Apr 2013
- First submitted
- 7 Feb 2012
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fellahi JL, Brossier D, Dechanet F, Fischer MO, Saplacan V, Gerard JL, Hanouz JL. Early goal-directed therapy based on endotracheal bioimpedance cardiography: a prospective, randomized controlled study in coronary surgery. J Clin Monit Comput. 2015 Jun;29(3):351-8. doi: 10.1007/s10877-014-9611-5. Epub 2014 Nov 9.
PubMed 25380955
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Goal-directed Hemodynamic Therapy Driven by Endotracheal Cardiac Output Monitoring System During Surgical Intervention Reduce Hospital Stay and Major Adverse Cardiac Events Following Cardiac Surgery?
- ClinicalTrials.gov ID
- NCT01535716
- Acronym / sponsor ID
- ECOMIII / 2011-A01210-41
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- CONMED Corporation
- Study start
- Feb 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Feb 2012 (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.
Goal-directed hemodynamic and fluid optimizations are shown to be a key factor of the medical care during anesthesia.According to medical literature, goal-directed fluid and hemodynamic optimizations are more efficient when based on the dynamic parameters than when based on the statics ones, and the major dynamic criteria is the cardiac output. Unfortunately, transpulmonary thermodilution, the device considered as "The gold standard" to evaluate cardiac output is associated with many complications.Furthermore, devices commercialized in the past decade were not able to replace the transpulmonary thermodilution.
As all monitoring devices aren't reliable enough to be widely used in practice they are left aside in benefits of the clinical evaluation. Even though, hemodynamic optimization based on the analysis of several clinical parameters seems to guarantee good cares thanks to a favorable benefits/risks balance, it could be improved by new plug and play mini-invasive systems.
In the investigators opinion, the ECOM system seems able to provide a monitoring tool which responds to all the expectations of a modern hemodynamic monitoring device. It uses a well known technique, the bioimpedance. The investigators suppose this device should be more efficient than the one that has been used before. Indeed, as the system is build on the endotracheal tube, it comes closer to the aorta, where all the measures are made, and the recorded signal should be less affected by the passage through the surrounding tissues.
This randomized and controlled trial will study Patients scheduled for elective coronary surgery with cardiopulmonary bypass.
The purpose of this trial is to evaluate the benefits of an intraoperative goal-directed hemodynamic therapy based on the ECOM cardiac output measure on mortality and major postoperative cardiac morbidity after coronary surgery, when compared with a standard management strategy.
Patients will be allocated into control and ECOM groups, of 50 peoples each. The standard management strategy, applied to the control group, will be set and led by the attending anesthetist, based on the analysis of further clinical parameters. The ECOM Group will face the hemodynamic optimization strategy led by the ECOM evaluation of cardiac output and stroke volume variation.
The main hypothesis is that the hemodynamic strategy led by the ECOM cardiac output measure will reduce mortality and morbidity after cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECOM group | Experimental | Behavioral: hemodynamic optimization strategy driven by the ECOM50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass |
| standard management group | Active comparator | Behavioral: standard management strategy50 Patients scheduled for elective coronary surgery with cardiopulmonary bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any man or woman
- Over 18 year-old
- After obtaining written informed consent
- Scheduled for elective coronary surgery with CPB
Key exclusion criteria (6 listed)
- Emergency surgery (< 24h)
- Combined cardiac surgery
- Patients < 18 years-old and/or unable to give informed consent
- Patients who refuse to give informed consent
- 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 |
|---|---|---|
| hemodynamic optimization strategy driven by the ECOMAlso: Endotracheal cardiac output monitoringgoal directed hemodynamic therapy is based on the ECOM evaluation of stroke volume variation (SVV) \& cardiac index (CI). goals: * SVV < 11% * IC > 2,2 ml/min/m² During the anesthesia | Behavioural | ECOM group |
| standard management strategygoal directed hemodynamic therapy will be set and performed by the attending anesthetist, based on the analysis of further clinical parameters: Standard monitoring : heart rate, saturation index * Diuresis > 0,5ml/kg/h * Blood pressure , PAM > 65 mmHg * Pulse pressure variation * CVP 8 to 12 cmH20 * Visual aspect of the heart * Overload signs During the anesthesia | Behavioural | standard management group |
Primary outcome
length of hospital stay
Time frame: Data collected at the exit of hospital or at death, if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days. expected before 1 month
4 secondary outcomes
Number of major adverse cardiac events during stay in hospital
Time frame: Data collected at the exit of ICU, at the exit of hospital or at death if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days.Up to 1 month
Length of stay in ICU
Time frame: at the exit of ICU or at death, if during hospital stay.expected before 1 month
In-hospital mortality
Time frame: at the end of the study. up to 12 month
Number of patients with Major adverse cardiac events during in-hospital stay.
Time frame: at the end of the study. Up to 12 month
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 2 Apr 2026.
- Results publication: PubMed 25380955Fellahi JL, Brossier D, Dechanet F, Fischer MO, Saplacan V, Gerard JL, Hanouz JL. Early goal-directed therapy based on endotracheal bioimpedance cardiography: a prospective, randomized controlled study in coronary surgery. J Clin Monit Comput. 2015 Jun;29(3):351-8. doi: 10.1007/s10877-014-9611-5. Epub 2014 Nov 9.
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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.
Jean-Luc Fellahi study director
EA3212: groupe coeur et ischémie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hemodynamic optimization strategy driven by the ECOM and standard management strategy in people with Coronary Surgery With Cardiopulmonary Bypass, run by University Hospital, Caen 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 6 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 2 Apr 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
length of hospital stay (time frame: Data collected at the exit of hospital or at death, if during hospital stay.patients will be followed for the duration of hospital stay, an expected average of 10 days. expected before 1 month). 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 NCT01535716, 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 2 Apr 2026.