An interventional study of Personalized Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation and Respiratory Failure Patients Treated With ECMO, sponsored by University of California, San Diego. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of California, San Diego · Not applicable, Interventional, and Treatment
While mechanical ventilation can be used to sustain life in those with lung injury, it, can further worsen lung injury or prevent lung healing resulting in high morbidity and mortality as seen in Acute Respiratory Distress Syndrome (ARDS).
Using extracorporeal membrane oxygenation (ECMO), the highest level of life support also known as the heart-lung machine, investigators may minimize injury from mechanical ventilation to allow the lungs to heal; however, the optimal ventilator strategies while on ECMO are unknown. This study will evaluate personalized ventilator strategy compared to standard of care ventilation.
While mechanical ventilation can be used to sustain life in those with severe ARDS, it, can further worsen lung injury or prevent lung healing resulting in high morbidity and mortality. Using ECMO, investigators may be able to minimize injury from mechanical ventilation to allow the lungs to to recover from ARDS; however, the optimal ventilator settings and therapies are unknown while on ECMO. This trial will randomize patients to personalized ventilator strategy vs. standard of care.
Current ventilator guidelines while on V-V ECMO for ARDS use a one-size-fits-all approach - respiratory rate 10, driving pressure 10, and a PEEP of 10. Our central hypothesis is that personalized PEEP adjusted by measuring intrathoracic pressures via esophageal manometry (Pes) will decease ventilator induced lung injury (VILI) as assessed by biomarkers of inflammation (main outcomes IL-6 and sRAGE).
To carry out these aims, participants with ARDS on V-V ECMO will be prospectively randomize patients to two groups:
Control Arm: PEEP of 10 cmH2O (ECMO guidelines). Intervention Arm: PEEP guided by esophageal manometry. Both arms will have be on neuromuscular blockade, with a respiratory rate set at 10 breaths/min and a driving pressure of 10 cmH2O.
In addition to biomarkers of VILI, investigators will assess differences in other physiological outcomes including pulmonary mechanics and gas exchange.
Hypothesis: Personalized PEEP will have improvement in biomarkers (primary outcome - IL-6), increased oxygenation, decreased dead space, and increased respiratory compliance.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 62 is close to the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with to esophageal balloon placement or inability to successfully place an esophageal balloon will have personalized PEEP determined by electrical impedance tomography.
a. Contraindications include recently treated or bleeding varices, esophageal stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement, or severe coagulopathy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Classic ventilator settings for patients on ECMO. Pressure control, with a respiratory rate of 10, driving pressure of 10, and PEEP of 10.
Classic ventilator settings for patients on ECMO. Pressure control, with a respiratory rate of 10, driving pressure of 10, and a personalized PEEP (intervention)
Device: Personalized Positive End-Expiratory Pressure (PEEP)
The personalized Positive End-Expiratory Pressure (PEEP) will be determined by esophageal manometry or electrical impedance tomography (EIT)
Also known as: Esophageal manometry, Titration of PEEP by end-expiratory transpulmonary pressure, Titration of PEEP by electrical impedance tomography (EIT)
Biomarker outcome (IL-6)
IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS.
Time frame: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment.
Respiratory gas exchange (dead space, oxygenation).
Arterial oxygenation (mmHg) will be assessed with the arterial blood gas. Deadspace fraction (unitless) will be calculated by the end-title CO2 monitoring.
Time frame: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment.
Respiratory mechanics (compliance of the respiratory system)
Compliance (ml/cmH2O) and tidal volumes (milliliters) will be measured by the ventilator.
Time frame: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment.
Plan to share: Yes — The data will be archived at the NHLBI BioData Catalyst (biodatacatalyst.nhlbi.nih.gov), which is an NIH repository for heart, lung, blood, and sleep research. Data will be made available for investigators subject to submission of a data access and subsequent approval by the BioData Catalyst. The approval will be contingent upon several factors, including verification of the investigator having valid scientific rationale and relevant institutional review board approval.
Start is estimated for Nov 2026; primary completion for Jun 2030, 43 months later.
Of 263 non-industry interventional studies with no phase under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 43 months is above that.
Counting every sponsor, half of 270 studies reached it within 24 months; a quarter within 12 and three quarters within 42.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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