Cardiac ArrestNCT04739007
Pulmonary Physiologic Assessment of Patients on Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)
An observational study of Cardiac Arrest and Pulmonary Injury, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
There is limited data on the respiratory system mechanics and ideal mode of ventilation for patients on veno-arterial extra-corporeal membrane oxygenation (VA ECMO) post cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Pulmonary Injury
- What is being tested?
- Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) and Electrical Impedance Tomography (EIT)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2021to 8 Nov 2022
- 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 without underlying pulmonary disease on VA ECMO post-cardiac arrest
Who may be able to join
- On VA ECMO after cardiac arrest
- Between 18 and 85 years of age
- Has an orogastric or nasogastric tube with esophageal balloon capabilities in place
Who cannot join
- Known pre-existing significant pulmonary pathology
- Pacemaker or implanted cardiac defibrillator
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02135
About this study
There is limited data on the respiratory system mechanics and ideal mode of ventilation for patients on veno-arterial extra-corporeal membrane oxygenation (VA ECMO) post cardiac arrest. In this observational study, the investigators will review and/or obtain laboratory, hemodynamic, respiratory system mechanical, and clinical data from patients on VA ECMO. The specific aims of this study are as follows:
Aim 1: To characterize the lung ventilation strategy employed in patients on VA ECMO and its success.
Read more
Aim 2: To characterize respiratory system mechanics while on ECMO using esophageal manometry and Electrical Impedance Tomography (EIT).
Aim 3: To characterize right heart function and pulmonary vascular hemodynamics on the employed ventilation strategy.
The overarching hypothesis is that fine-tuned individualized ventilation might be superior to an algorithm that does not account for cardiac and pulmonary functions. Therefore, the aims of this study are to identify areas in which the ventilation strategy may theoretically be suboptimal, which will guide future interventional studies investigating alternatives methods of ventilation which may reduce time on the ventilator after cardiac arrest, time in the intensive care unit, and need for veno-venous ECMO.
- Conditions
- Cardiac Arrest, Pulmonary Injury
- Being tested
- Veno-arterial extracorporeal membrane oxygenation (VA-ECMO), Electrical Impedance Tomography (EIT)
- Medical subject headings
- Heart Arrest, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veno-arterial extracorporeal membrane oxygenation (VA-ECMO)Procedure or surgery
VA-ECMO used for resuscitation after cardiac arrest
Electrical Impedance Tomography (EIT)Device
EIT used to demonstrate ventilation and perfusion distribution in intubated patients on VA-ECMO
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of total distribution of ventilation by region, on given ventilator settings
EIT will be used to determine the percent of total ventilation occurring in each of four lung quadrants on an axial plane: right upper, left upper, right lower, and left lower.
Measured: Within 24-48 hours of ECMO cannulation
Secondary outcomes (6)
Time on VA-ECMO
Measured: 14 days, 90 days
Need to transition to VV-ECMO
Measured: 14 days, 90 days
Time on mechanical ventilation
Measured: 14 days, 90 days
Time in ICU
Measured: 14 days, 90 days
90-day mortality
Measured: 90 days
Incidence of ventilator-associated pneumonia
Measured: 14 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start9 Jan 2021
- Primary completionDec 2021 (estimated)
- Study completion8 Nov 2022
Why it stopped: Not enough personnel to follow the trial- study was withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Berra, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739007
- Sponsor's protocol ID
- 2020P003054
- Status last verified
- Nov 2022
- First submitted
- 28 Jan 2021
- Last updated
- 10 Nov 2022
- Results posted
- 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 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Physiologic Assessment of Patients on Veno-arterial Extracorporeal Membrane Oxygenation (VA ECMO)
- ClinicalTrials.gov ID
- NCT04739007
- Acronym / sponsor ID
- 2020P003054
- Conditions
- Cardiac Arrest, Pulmonary Injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not enough personnel to follow the trial- study was withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 4 Feb 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.
There is limited data on the respiratory system mechanics and ideal mode of ventilation for patients on veno-arterial extra-corporeal membrane oxygenation (VA ECMO) post cardiac arrest. In this observational study, the investigators will review and/or obtain laboratory, hemodynamic, respiratory system mechanical, and clinical data from patients on VA ECMO. The specific aims of this study are as follows:
Aim 1: To characterize the lung ventilation strategy employed in patients on VA ECMO and its success.
Aim 2: To characterize respiratory system mechanics while on ECMO using esophageal manometry and Electrical Impedance Tomography (EIT).
Aim 3: To characterize right heart function and pulmonary vascular hemodynamics on the employed ventilation strategy.
The overarching hypothesis is that fine-tuned individualized ventilation might be superior to an algorithm that does not account for cardiac and pulmonary functions. Therefore, the aims of this study are to identify areas in which the ventilation strategy may theoretically be suboptimal, which will guide future interventional studies investigating alternatives methods of ventilation which may reduce time on the ventilator after cardiac arrest, time in the intensive care unit, and need for veno-venous ECMO.
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 without underlying pulmonary disease on VA ECMO post-cardiac arrest
Key inclusion criteria (3 listed)
- On VA ECMO after cardiac arrest
- Between 18 and 85 years of age
- Has an orogastric or nasogastric tube with esophageal balloon capabilities in place
Key exclusion criteria (2 listed)
- Known pre-existing significant pulmonary pathology
- Pacemaker or implanted cardiac defibrillator
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 |
|---|---|---|
| Veno-arterial extracorporeal membrane oxygenation (VA-ECMO)VA-ECMO used for resuscitation after cardiac arrest | Procedure or surgery | – |
| Electrical Impedance Tomography (EIT)EIT used to demonstrate ventilation and perfusion distribution in intubated patients on VA-ECMO | Device | – |
Primary outcome
Percent of total distribution of ventilation by region, on given ventilator settings
Time frame: Within 24-48 hours of ECMO cannulation
EIT will be used to determine the percent of total ventilation occurring in each of four lung quadrants on an axial plane: right upper, left upper, right lower, and left lower.
6 secondary outcomes
Time on VA-ECMO
Time frame: 14 days, 90 days
Need to transition to VV-ECMO
Time frame: 14 days, 90 days
Time on mechanical ventilation
Time frame: 14 days, 90 days
Time in ICU
Time frame: 14 days, 90 days
90-day mortality
Time frame: 90 days
Incidence of ventilator-associated pneumonia
Time frame: 14 days, 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- 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. 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 Cardiac Arrest and Pulmonary Injury, run by Massachusetts General Hospital at 1 site 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 10 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent of total distribution of ventilation by region, on given ventilator settings (time frame: Within 24-48 hours of ECMO cannulation). 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 10 Nov 2022.