Residual Cardiac Output During PVA-ECMOCAPNOECMONCT03323268
Use of Exhaled Carbon Dioxyde for Monitoring the Native Cardiac Function During Mechanical Circulatory Support With Venoarterial By-pass in Intensive Care Unit
An observational study of Residual Cardiac Output During PVA-ECMO, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Cardiogenic shock, the most severe form of acute heart failure, is a critical situation where the body cells lack of oxygen because of cardiac dysfunction. The failure of pharmacological therapy to maintain adequate perfusion has led to attempts to improve the circulation by the use of mechanical circulatory support… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Residual Cardiac Output During PVA-ECMO
- What is being tested?
- PetCO2 monitoring
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2016to 23 Oct 2017
- 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: Patients under mechanical ventilation and PVA-ECMO support
Who may be able to join
- Patients under mechanical ventilation and PVA-ECMO support with low residual native cardiac output
Who cannot join
- age less than 18 years
- pulmonary disorders with abnormal dead-space (obstructive pulmonary disease; acute respiratory distress syndrome)
- cardiac shunt (atrial or ventricular communication)
- significant tricuspid or pulmonary valve disease
- pulmonary artery catheter implantation contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of End-tidal CO2 for Transplumonary Blood Flow Monitoring During PVA-ECMO
Cardiogenic shock, the most severe form of acute heart failure, is a critical situation where the body cells lack of oxygen because of cardiac dysfunction. The failure of pharmacological therapy to maintain adequate perfusion has led to attempts to improve the circulation by the use of mechanical circulatory support devices. Peripheral veno-arterial support (PVA-ECMO) is the most frequently used device. It consists of extracorporeal circulatory support. Venous blood is aspirated via the right atrium and reinjected into the descending aorta via the femoral artery. As a consequence of this by-pass, pulmonary artery flow and residual left ventricle ejection can fall drastically until zero in the most severe patients. A minimal transpulmonary blood flow is crucial to avoid left heart cavities and pulmonary artery and left heart cavities thrombosis. The gold standard technique to monitor transpulmonary blood flow is right-heart cavities catheterism (Swan-Ganz catheter) but it represents major limits: invasive technique, limited duration of utilization because of septic risk, physical limit of flow measurement (under 1 liter/minute). End-tidal pressure carbon dioxide (Pet CO2) monitoring (or capnography) is a routine and non-invasive measure in ventilated patients. Previous studies have shown that changes in PetCO2 can measure changes in cardiac output in anesthetized patients and that PetCO2 is a useful index of pulmonary artery blood flow during separation from cardiopulmonary bypass. The aim of this study is to demonstrate that PetCO2 is correlated to transpulmonary blood flow in patients under PVA-ECMO and that exhaled CO2 can provide an on-line, continuous, and noninvasive monitor of residual outflow from the heart during PVA-ECMO.
Read the detailed description
Settings
This prospective study is conducted since January 2016 in our tertiary ICU and has been approved by our hospital's institutional review board. Informed consent will be obtained from all patients or their surrogates.
Hemodynamic is monitored via a radial arterial catheter for continuous blood pressure monitoring, a pulmonary artery catheter (Swan-Ganz CCOmbo® CCO/SvO2, Edwards Lifesciences) inserted through the superior vena cava (jugular intern or subclavian vein) and transoesophageal echocardiography (TOE) at PVA-ECMO implantation or at operator discretion.
ECMO circuit settings and patients management under ECMO
PVA-ECMO consist of polyvinyl chloride tubing with a membrane oxygenator (PH.I.S.I.O and EOS; Sorin Group, Clamart, France), a centrifugal pump (Stockert; Sorin Group), and percutaneous or surgically inserted arterial and venous femoral cannulae (Fem-Flex and Fem-Track, Edwards Life- sciences, Guyancourt, France) with or without an additional 7 F cannula inserted distally into the femoral artery to prevent lower limb ischemia. An oxygen-air blender (Sechrist Industries, Anaheim, CA) ventilate the membrane oxygenator. Unfractionated heparin is administrated to maintain an activated partial thromboplastin time between 1.5 and 2 times the normal value. The lower speed flow necessary for adequate tissue perfusion is wanted.
Ventilator settings, end-tidal PCO2 monitoring, blood gas analysis and transpulmonary blood flow monitoring
- Conditions
- Residual Cardiac Output During PVA-ECMO
- Being tested
- PetCO2 monitoring
- Keywords
- Intensive care, Cardiogenic shock, Peripheral veno-arterial extracorporeal membrane oxygenation, Left ventricular overload, Native cardiac output, Pulmonary artery blood flow, End-tidal carbon dioxide, Swan Ganz catheter, Blood gaz
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PetCO2 monitoringDevice
CO2 analyzer on ventilator expiratory lane. On-line, continuous, and noninvasive monitor. Routine use in anesthesia and intensive care units.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of end-tidal pressure CO2 (PetCO2) correlation with pulmonary artery flow
end-tidal pressure CO2 (PetCO2) vs pulmonary artery flow measured by pulmonary catheter or echocardiography
Measured: Up to 5 days
Secondary outcomes (2)
Assessment of end-tidal pressure CO2 (PetCO2) thresholds to detect pulmonary artery flow < 1 l/min and indexed flow < 1l/min/m2
Measured: Up to 5 days
Assessment of Factors of end-tidal pressure CO2 (PetCO2) variation
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start12 Jan 2016
- Primary completion23 Oct 2016
- Study completion23 Oct 2017
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 Residual Cardiac Output During PVA-ECMOStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323268
- Sponsor's protocol ID
- 9653
- Acronym
- CAPNOECMO
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: unkown
Publications
Mourad M, Eliet J, Zeroual N, Saour M, Sentenac P, Manna F, Molinari N, Gandet T, Colson PH, Gaudard P. Pulse pressure and end-tidal carbon dioxide for monitoring low native cardiac output during veno-arterial ECLS: a prospective observational study. Crit Care. 2020 Sep 22;24(1):569. doi: 10.1186/s13054-020-03280-z.
PubMed 32962727
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of End-tidal CO2 for Transplumonary Blood Flow Monitoring During PVA-ECMO
- ClinicalTrials.gov ID
- NCT03323268
- Acronym / sponsor ID
- CAPNOECMO / 9653
- Conditions
- Residual Cardiac Output During PVA-ECMO
- Keywords
- Intensive care, Cardiogenic shock, Peripheral veno-arterial extracorporeal membrane oxygenation, Left ventricular overload, Native cardiac output, Pulmonary artery blood flow, End-tidal carbon dioxide, Swan Ganz catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 23 Oct 2016 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 26 Oct 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.
Cardiogenic shock, the most severe form of acute heart failure, is a critical situation where the body cells lack of oxygen because of cardiac dysfunction. The failure of pharmacological therapy to maintain adequate perfusion has led to attempts to improve the circulation by the use of mechanical circulatory support devices. Peripheral veno-arterial support (PVA-ECMO) is the most frequently used device. It consists of extracorporeal circulatory support. Venous blood is aspirated via the right atrium and reinjected into the descending aorta via the femoral artery. As a consequence of this by-pass, pulmonary artery flow and residual left ventricle ejection can fall drastically until zero in the most severe patients. A minimal transpulmonary blood flow is crucial to avoid left heart cavities and pulmonary artery and left heart cavities thrombosis. The gold standard technique to monitor transpulmonary blood flow is right-heart cavities catheterism (Swan-Ganz catheter) but it represents major limits: invasive technique, limited duration of utilization because of septic risk, physical limit of flow measurement (under 1 liter/minute). End-tidal pressure carbon dioxide (Pet CO2) monitoring (or capnography) is a routine and non-invasive measure in ventilated patients. Previous studies have shown that changes in PetCO2 can measure changes in cardiac output in anesthetized patients and that PetCO2 is a useful index of pulmonary artery blood flow during separation from cardiopulmonary bypass. The aim of this study is to demonstrate that PetCO2 is correlated to transpulmonary blood flow in patients under PVA-ECMO and that exhaled CO2 can provide an on-line, continuous, and noninvasive monitor of residual outflow from the heart during PVA-ECMO.
Detailed description
Settings
This prospective study is conducted since January 2016 in our tertiary ICU and has been approved by our hospital's institutional review board. Informed consent will be obtained from all patients or their surrogates.
Hemodynamic is monitored via a radial arterial catheter for continuous blood pressure monitoring, a pulmonary artery catheter (Swan-Ganz CCOmbo® CCO/SvO2, Edwards Lifesciences) inserted through the superior vena cava (jugular intern or subclavian vein) and transoesophageal echocardiography (TOE) at PVA-ECMO implantation or at operator discretion.
ECMO circuit settings and patients management under ECMO
PVA-ECMO consist of polyvinyl chloride tubing with a membrane oxygenator (PH.I.S.I.O and EOS; Sorin Group, Clamart, France), a centrifugal pump (Stockert; Sorin Group), and percutaneous or surgically inserted arterial and venous femoral cannulae (Fem-Flex and Fem-Track, Edwards Life- sciences, Guyancourt, France) with or without an additional 7 F cannula inserted distally into the femoral artery to prevent lower limb ischemia. An oxygen-air blender (Sechrist Industries, Anaheim, CA) ventilate the membrane oxygenator. Unfractionated heparin is administrated to maintain an activated partial thromboplastin time between 1.5 and 2 times the normal value. The lower speed flow necessary for adequate tissue perfusion is wanted.
Ventilator settings, end-tidal PCO2 monitoring, blood gas analysis and transpulmonary blood flow monitoring
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under mechanical ventilation and PVA-ECMO support
Key inclusion criteria (1 listed)
- Patients under mechanical ventilation and PVA-ECMO support with low residual native cardiac output
Key exclusion criteria (5 listed)
- age less than 18 years
- pulmonary disorders with abnormal dead-space (obstructive pulmonary disease; acute respiratory distress syndrome)
- cardiac shunt (atrial or ventricular communication)
- significant tricuspid or pulmonary valve disease
- pulmonary artery catheter implantation contraindicated.
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 |
|---|---|---|
| PetCO2 monitoringCO2 analyzer on ventilator expiratory lane. On-line, continuous, and noninvasive monitor. Routine use in anesthesia and intensive care units. | Device | – |
Primary outcome
Assessment of end-tidal pressure CO2 (PetCO2) correlation with pulmonary artery flow
Time frame: Up to 5 days
end-tidal pressure CO2 (PetCO2) vs pulmonary artery flow measured by pulmonary catheter or echocardiography
2 secondary outcomes
Assessment of end-tidal pressure CO2 (PetCO2) thresholds to detect pulmonary artery flow < 1 l/min and indexed flow < 1l/min/m2
Time frame: Up to 5 days
Assessment of Factors of end-tidal pressure CO2 (PetCO2) variation
Time frame: Up to 5 days
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 26 Oct 2017.
- Derived from this study: PubMed 32962727Mourad M, Eliet J, Zeroual N, Saour M, Sentenac P, Manna F, Molinari N, Gandet T, Colson PH, Gaudard P. Pulse pressure and end-tidal carbon dioxide for monitoring low native cardiac output during veno-arterial ECLS: a prospective observational study. Crit Care. 2020 Sep 22;24(1):569. doi: 10.1186/s13054-020-03280-z.
- Individual participant dataSharing planned: Yes. unkown
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 Residual Cardiac Output During PVA-ECMO, run by University Hospital, Montpellier 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 5 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 26 Oct 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?
Assessment of end-tidal pressure CO2 (PetCO2) correlation with pulmonary artery flow (time frame: Up to 5 days). 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 NCT03323268, 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 26 Oct 2017.