Acute Respiratory Distress SyndromePiCCMONCT05164484
Assessment of Cardiac Output in Patients With ARDS Implanted With Venous-venous ECMO.
A study testing Transpulmonary thermodilution in people with Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In patients with severe acute respiratory distress syndrome, extracorporeal membrane oxygenation (ECMO), which also as known as extracorporeal life support, may be used. This technique helps the lungs by providing oxygenation to the blood via an external gas exchanger and thus participates partially or fully in gas… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Transpulmonary thermodilution
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2021to 15 Jan 2025
- 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
- ≥18yrs.
- With acute respiratory distress syndrome.
- Monitored by transpulmonary thermodilution device.
- Implanted by VV-ECMO.
- Affiliated to the French Health Insurance
Who cannot join
- Pregnancy
- Patient placed under judicial protection
- Patient on state medical aid (AME, Aide Medicale d'Etat)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de médecine intensive-réanimation de l'Hôpital Bicêtre
Le Kremlin-Bicêtre
Christopher LAI, M.D., 33 (0)1 45 21 26 71, christopher.lai@aphp.fr
Xavier MONNET, M.D., Ph.D., 33 (0)6 60 86 26 69, xavier.monnet@aphp.fr
About this study
Official title: Assessment of Cardiac Output by Transpulmonary Thermodilution and Pulse Contour Analysis in Patients With ARDS Implanted by Venous-venous ECMO
In patients with severe acute respiratory distress syndrome, extracorporeal membrane oxygenation (ECMO), which also as known as extracorporeal life support, may be used. This technique helps the lungs by providing oxygenation to the blood via an external gas exchanger and thus participates partially or fully in gas exchange. The ECMO device includes a pump for draining and returning blood at a certain blood flow rate (ECMO blood flow). An ECMO rate that is adapted to the patient's cardiac output (CO) is essential for effective oxygenation for patients. The objective for clinicians is an ECMO blood flow to cardiac output ≥40%, which can go up to 100% as needed. In addition to the expected benefit in the management of the patient with ARDS, measuring CO is, therefore, all the more important in patients requiring ECMO.
Monitoring CO in a patient with ECMO is not only for determining the minimum ECMO blood flow rate but also for optimizing the functioning of the ECMO. However, the validity of techniques for measuring CO in patients with ECMO has been poorly studied. The reliability of the CO measurement by transpulmonary thermodilution is questioned since the extracorporeal circulation may influence the pathway of cold indicator injected into the patients' circulation and the thermodilution curve measured from the femoral arterial is thereby modified.
Read the detailed description
Acute respiratory distress syndrome (ARDS) is a severe and common condition with up to 45% mortality in ICU. Its respiratory management includes "protective" mechanical ventilation, the use of a positive end-expiratory pressure level, sometimes the performance of recruitment maneuvers or prone position, and the use of neuromuscular blockers. Due to heart-lung interactions, these different strategies can induce significant or even deleterious hemodynamic effects. Thus, hemodynamic monitoring in such patients is essential. It could assess the effect of ventilatory settings and optimize hemodynamic management. Optimization of arterial oxygen transport in hypoxemic patients may require an increase in the patient's cardiac output (CO). Fluid administration is one of the first-line strategies for achieving this objective. However, unnecessary fluid administration can lead to an increase in pulmonary edema and thus increase the duration of mechanical ventilation and hospitalization. Transpulmonary thermodilution is one of the advanced hemodynamic monitoring in ICU, which consists of the injection of three boluses of cold saline of 15 ml through a central venous catheter located in the superior vena cava, causing a drop in blood temperature which is detected by a femoral arterial catheter equipped with a thermistor. It was demonstrated to be a reliable and simple technique at the bedside for measuring CO. Combined with another technique, pulse contour analysis analysis, transpulmonary thermodilution allows to measure CO beat-to-beat. In addition, transpulmonary thermodilution can measure various hemodynamic variables of interest such as the global end-diastolic volume index (GEDVI, cardiac preload index), the cardiac function index (CFI, cardiac contractility index), extravascular lung water index (EVLWI, volume of fluid accumulated in the alveolar and interstitial lung sectors) and the pulmonary vascular permeability index (PVPI). The last two indices are particularly interesting in patients with ARDS, and were shown to be associated with mortality in patients with ARDS independently. In severe ARDS, ECMO may be another choice. This technique helps the lungs to rest by providing oxygenation to the blood via an external gas exchanger and thus participates partially or fully in gas exchange. The ECMO includes a central pump for draining and returning blood at a given blood flow rate (ECMO blood flow rate). The recommended oxygenation target for patients receiving venous-venous extracorporeal membrane oxygenation (VV-ECMO) assistance is when peripheral oxygen saturation (SpO2) is ≥80%. An ECMO blood flow rate adapted to the patient's CO is essential for effective extracorporeal oxygenation. The objective is an ECMO blood flow /CO ≥40%. It can also go up to 100% as needed (8). This rate can be modified by adjusting the central pump. Thus, it is obvious that measuring CO is important in patients requiring ECMO. However, the techniques measuring CO in patients with ECMO have been poorly studied. the reliability of the measurement of transpulmonary thermodilution was questioned since the analysis of the thermodilution curve can be modified by the extracorporeal circulation. This effect does not matter in a low flow extracorporeal deviation, such as that which is achieved for example during a continuous extrarenal purification . Some studies have shown that transpulmonary thermodilution measurements remain reliable when using another extracorporeal circuit, extracorporeal carbon dioxide removal, whose flow rate can go up to 2.4 L / min. It could be different from ECMO, the blood flow of which is higher. The only available study, conducted by Herner et al, demonstrated the reliability of measuring CO by transpulmonary thermodilution during ECMO. However, the ECMO blood flow/CO ratio was only around 40% in this study. For higher ECMO blood flow/CO ratio (> 40%), the problem remains unresolved.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Transpulmonary thermodilution
- Keywords
- ARDS, Venovenous Extracorporeal Membrane Oxygenation, Pulmonary Thermodilution, Cardiac Output
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpulmonary thermodilutionDevice
Through the analysis of the thermodilution curve recorded at the tip of an arterial catheter after the injection of a cold bolus in the venous circulation, transpulmonary thermodilution intermittently measures cardiac output.
| Study group | Role | What they receive |
|---|---|---|
| Transpulmonary thermodilution in patients implanted with VV-ECMO during standard care for ARDS | Other | Standard of care procedure for patient with severe ARDS Receives: Device: Transpulmonary thermodilution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of CO by transpulmonary thermodilution compared to CO measured by echocardiography
Standard measurements by injection of three cold bolus in the venous circulation for transpulmonary thermodilution and standard echocardiography procedures.
Measured: The first week during patient is under ECMO assistance
Secondary outcomes (5)
The CO measurements by pulse contour analyse at different ECMO blood flow/CO ratio.
Measured: The first week during patient is under ECMO assistance
The changes of transpulmonary thermodilution parameter :GEDVI measured at different ECMO blood flow/CO ratio.
GEDVI (Global end diastolic volume index) measured in mL/m^2
Measured: The first week during patient is under ECMO assistance
The changes of transpulmonary thermodilution parameter : CFI measured at different ECMO blood flow/CO ratio.
CFI (Cardiac function index) measured in 1/min
Measured: The first week during patient is under ECMO assistance
The changes of transpulmonary thermodilution parameters : EVLWI measured at different ECMO blood flow/CO ratio.
EVLWI (Extravascular Lung Water index) measured in mL/kg
Measured: The first week during patient is under ECMO assistance
The changes of transpulmonary thermodilution parameter : PVPI (Pulmonary Vascular Permeability Index) measured at different ECMO blood flow/CO ratio.
Measured: The first week during patient is under ECMO assistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start19 Jan 2021
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher LAI, M.D., Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164484
- Sponsor's protocol ID
- APHP210562
- Other IDs
- 2020-A03287-32
- Acronym
- PiCCMO
- Status last verified
- Nov 2022
- First submitted
- 1 Oct 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac Output by Transpulmonary Thermodilution and Pulse Contour Analysis in Patients With ARDS Implanted by Venous-venous ECMO
- ClinicalTrials.gov ID
- NCT05164484
- Acronym / sponsor ID
- PiCCMO / APHP210562
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Venovenous Extracorporeal Membrane Oxygenation, Pulmonary Thermodilution, Cardiac Output
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 20 Dec 2021 (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.
In patients with severe acute respiratory distress syndrome, extracorporeal membrane oxygenation (ECMO), which also as known as extracorporeal life support, may be used. This technique helps the lungs by providing oxygenation to the blood via an external gas exchanger and thus participates partially or fully in gas exchange. The ECMO device includes a pump for draining and returning blood at a certain blood flow rate (ECMO blood flow). An ECMO rate that is adapted to the patient's cardiac output (CO) is essential for effective oxygenation for patients. The objective for clinicians is an ECMO blood flow to cardiac output ≥40%, which can go up to 100% as needed. In addition to the expected benefit in the management of the patient with ARDS, measuring CO is, therefore, all the more important in patients requiring ECMO.
Monitoring CO in a patient with ECMO is not only for determining the minimum ECMO blood flow rate but also for optimizing the functioning of the ECMO. However, the validity of techniques for measuring CO in patients with ECMO has been poorly studied. The reliability of the CO measurement by transpulmonary thermodilution is questioned since the extracorporeal circulation may influence the pathway of cold indicator injected into the patients' circulation and the thermodilution curve measured from the femoral arterial is thereby modified.
Detailed description
Acute respiratory distress syndrome (ARDS) is a severe and common condition with up to 45% mortality in ICU. Its respiratory management includes "protective" mechanical ventilation, the use of a positive end-expiratory pressure level, sometimes the performance of recruitment maneuvers or prone position, and the use of neuromuscular blockers. Due to heart-lung interactions, these different strategies can induce significant or even deleterious hemodynamic effects. Thus, hemodynamic monitoring in such patients is essential. It could assess the effect of ventilatory settings and optimize hemodynamic management. Optimization of arterial oxygen transport in hypoxemic patients may require an increase in the patient's cardiac output (CO). Fluid administration is one of the first-line strategies for achieving this objective. However, unnecessary fluid administration can lead to an increase in pulmonary edema and thus increase the duration of mechanical ventilation and hospitalization. Transpulmonary thermodilution is one of the advanced hemodynamic monitoring in ICU, which consists of the injection of three boluses of cold saline of 15 ml through a central venous catheter located in the superior vena cava, causing a drop in blood temperature which is detected by a femoral arterial catheter equipped with a thermistor. It was demonstrated to be a reliable and simple technique at the bedside for measuring CO. Combined with another technique, pulse contour analysis analysis, transpulmonary thermodilution allows to measure CO beat-to-beat. In addition, transpulmonary thermodilution can measure various hemodynamic variables of interest such as the global end-diastolic volume index (GEDVI, cardiac preload index), the cardiac function index (CFI, cardiac contractility index), extravascular lung water index (EVLWI, volume of fluid accumulated in the alveolar and interstitial lung sectors) and the pulmonary vascular permeability index (PVPI). The last two indices are particularly interesting in patients with ARDS, and were shown to be associated with mortality in patients with ARDS independently. In severe ARDS, ECMO may be another choice. This technique helps the lungs to rest by providing oxygenation to the blood via an external gas exchanger and thus participates partially or fully in gas exchange. The ECMO includes a central pump for draining and returning blood at a given blood flow rate (ECMO blood flow rate). The recommended oxygenation target for patients receiving venous-venous extracorporeal membrane oxygenation (VV-ECMO) assistance is when peripheral oxygen saturation (SpO2) is ≥80%. An ECMO blood flow rate adapted to the patient's CO is essential for effective extracorporeal oxygenation. The objective is an ECMO blood flow /CO ≥40%. It can also go up to 100% as needed (8). This rate can be modified by adjusting the central pump. Thus, it is obvious that measuring CO is important in patients requiring ECMO. However, the techniques measuring CO in patients with ECMO have been poorly studied. the reliability of the measurement of transpulmonary thermodilution was questioned since the analysis of the thermodilution curve can be modified by the extracorporeal circulation. This effect does not matter in a low flow extracorporeal deviation, such as that which is achieved for example during a continuous extrarenal purification . Some studies have shown that transpulmonary thermodilution measurements remain reliable when using another extracorporeal circuit, extracorporeal carbon dioxide removal, whose flow rate can go up to 2.4 L / min. It could be different from ECMO, the blood flow of which is higher. The only available study, conducted by Herner et al, demonstrated the reliability of measuring CO by transpulmonary thermodilution during ECMO. However, the ECMO blood flow/CO ratio was only around 40% in this study. For higher ECMO blood flow/CO ratio (> 40%), the problem remains unresolved.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transpulmonary thermodilution in patients implanted with VV-ECMO during standard care for ARDS | Other | Device: Transpulmonary thermodilutionStandard of care procedure for patient with severe ARDS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18yrs.
- With acute respiratory distress syndrome.
- Monitored by transpulmonary thermodilution device.
- Implanted by VV-ECMO.
- Affiliated to the French Health Insurance
Key exclusion criteria (3 listed)
- Pregnancy
- Patient placed under judicial protection
- Patient on state medical aid (AME, Aide Medicale d'Etat)
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 |
|---|---|---|
| Transpulmonary thermodilutionThrough the analysis of the thermodilution curve recorded at the tip of an arterial catheter after the injection of a cold bolus in the venous circulation, transpulmonary thermodilution intermittently measures cardiac output. | Device | Transpulmonary thermodilution in patients implanted with VV-ECMO during standard care for ARDS |
Primary outcome
The measurements of CO by transpulmonary thermodilution compared to CO measured by echocardiography
Time frame: The first week during patient is under ECMO assistance
Standard measurements by injection of three cold bolus in the venous circulation for transpulmonary thermodilution and standard echocardiography procedures.
5 secondary outcomes
The CO measurements by pulse contour analyse at different ECMO blood flow/CO ratio.
Time frame: The first week during patient is under ECMO assistance
The changes of transpulmonary thermodilution parameter :GEDVI measured at different ECMO blood flow/CO ratio.
Time frame: The first week during patient is under ECMO assistance
The changes of transpulmonary thermodilution parameter : CFI measured at different ECMO blood flow/CO ratio.
Time frame: The first week during patient is under ECMO assistance
The changes of transpulmonary thermodilution parameters : EVLWI measured at different ECMO blood flow/CO ratio.
Time frame: The first week during patient is under ECMO assistance
The changes of transpulmonary thermodilution parameter : PVPI (Pulmonary Vascular Permeability Index) measured at different ECMO blood flow/CO ratio.
Time frame: The first week during patient is under ECMO assistance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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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.
Christopher LAI, M.D. principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transpulmonary thermodilution in people with Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 5 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: status not confirmed, as of the sponsor's last update on 15 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher LAI, M.D. (33 (0)1 45 21 26 71, christopher.lai@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurements of CO by transpulmonary thermodilution compared to CO measured by echocardiography (time frame: The first week during patient is under ECMO assistance). 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 15 Nov 2022.