VA-ECMOECMO-VPNCT07141524
Optimizing Breathing and Blood Flow in Patients Treated With VA ECMO
A study testing Physiology measurements in people with VA-ECMO, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
The aim of this study is to characterize ventilation/perfusion (V/Q) matching in adult patients receiving peripheral VA ECMO support while on mechanical ventilation, and to evaluate the impact of PEEP titration guided by Electrical Impedance Tomography (EIT) and esophageal pressure measurements on lung mechanics and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VA-ECMO
- What is being tested?
- Physiology measurements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults (≥18 years) undergoing mechanical ventilation during peripheral VA ECMO support for cardiogenic shock, cardiac arrest, or refractory heart failure.
- On ECMO support for at least 6 hours
- Swan-Ganz catheter required as standard clinical care
- Clinically stable in the estimation of the study investigator
Who cannot join
- Contraindications to EIT (e.g., presence of electrical interference)
- Patients without pulmonary flow (non-pulsatile pulmonary pressure)
- Patients with known pulmonary embolism
- Imminent withdrawal of life support
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Ventilation-Perfusion Matching and PEEP Titration in Patients Undergoing Peripheral Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO)
The aim of this study is to characterize ventilation/perfusion (V/Q) matching in adult patients receiving peripheral VA ECMO support while on mechanical ventilation, and to evaluate the impact of PEEP titration guided by Electrical Impedance Tomography (EIT) and esophageal pressure measurements on lung mechanics and V/Q optimization.
Read the detailed description
The investigators hypothesize that an individualized PEEP titration guided by esophageal pressure measurements and Electrical Impedance Tomography can reduce lung overdistention, enhance lung recruitment, and improve V/Q matching by optimizing regional ventilation and perfusion also in VA ECMO.
Our objectives are:
- To describe V/Q matching in patients undergoing mechanical ventilation during peripheral VA ECMO support.
- To explore the impact of PEEP titration based on esophageal pressure and EIT in terms of lung mechanics and V/Q matching.
- Conditions
- VA-ECMO
- Being tested
- Physiology measurements
- Keywords
- Ventilation / perfusion, ECMO, Mechanical Ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiology measurementsOther
Measurement of lung perfusion (via EIT) and transpulmonary pressure (via esophageal manometry) during decremental PEEP trial
| Study group | Role | What they receive |
|---|---|---|
| Lung physiology assessment | Other | Measurement of lung perfusion (via EIT) and transpulmonary pressure (via esophageal manometry) during decremental PEEP trial Receives: Other: Physiology measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
V/Q match
Primary outcome measure:
Reduction in shunt fraction (expressed in %)
Secondary outcome measure:
Reduction in dead space (expressed as volume)
Respiratory mechanics will be recorded before and after best PEEP. Ventilation (L/min)/Perfusion (L/min) [V/Q] ratio comparing baseline with best PEEP (after PEEP optimization trial).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start27 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VA-ECMOStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Bottiroli, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141524
- Sponsor's protocol ID
- 2025P000675
- Acronym
- ECMO-VP
- Status last verified
- Oct 2025
- First submitted
- 19 Aug 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilation-Perfusion Matching and PEEP Titration in Patients Undergoing Peripheral Veno-Arterial Extracorporeal Membrane Oxygenation (VA ECMO)
- ClinicalTrials.gov ID
- NCT07141524
- Acronym / sponsor ID
- ECMO-VP / 2025P000675
- Conditions
- VA-ECMO
- Keywords
- Ventilation / perfusion, ECMO, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 26 Aug 2025 (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.
The aim of this study is to characterize ventilation/perfusion (V/Q) matching in adult patients receiving peripheral VA ECMO support while on mechanical ventilation, and to evaluate the impact of PEEP titration guided by Electrical Impedance Tomography (EIT) and esophageal pressure measurements on lung mechanics and V/Q optimization.
Detailed description
The investigators hypothesize that an individualized PEEP titration guided by esophageal pressure measurements and Electrical Impedance Tomography can reduce lung overdistention, enhance lung recruitment, and improve V/Q matching by optimizing regional ventilation and perfusion also in VA ECMO.
Our objectives are:
- To describe V/Q matching in patients undergoing mechanical ventilation during peripheral VA ECMO support.
- To explore the impact of PEEP titration based on esophageal pressure and EIT in terms of lung mechanics and V/Q matching.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung physiology assessment | Other | Other: Physiology measurementsMeasurement of lung perfusion (via EIT) and transpulmonary pressure (via esophageal manometry) during decremental PEEP trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years) undergoing mechanical ventilation during peripheral VA ECMO support for cardiogenic shock, cardiac arrest, or refractory heart failure.
- On ECMO support for at least 6 hours
- Swan-Ganz catheter required as standard clinical care
- Clinically stable in the estimation of the study investigator
Key exclusion criteria (4 listed)
- Contraindications to EIT (e.g., presence of electrical interference)
- Patients without pulmonary flow (non-pulsatile pulmonary pressure)
- Patients with known pulmonary embolism
- Imminent withdrawal of life support
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 |
|---|---|---|
| Physiology measurementsMeasurement of lung perfusion (via EIT) and transpulmonary pressure (via esophageal manometry) during decremental PEEP trial | Other | Lung physiology assessment |
Primary outcome
V/Q match
Time frame: 1 hour
Primary outcome measure: Reduction in shunt fraction (expressed in %) Secondary outcome measure: Reduction in dead space (expressed as volume) Respiratory mechanics will be recorded before and after best PEEP. Ventilation (L/min)/Perfusion (L/min) [V/Q] ratio comparing baseline with best PEEP (after PEEP optimization trial).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiology measurements in people with VA-ECMO, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
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 4 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: enrolling by invitation, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
V/Q match (time frame: 1 hour). 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 26 Aug 2026.