Acute Respiratory Distress Syndrome (ARDS)PEEPECMONCT07673250
Personalized Ventilator Settings for Patients on ECMO
A study testing Personalized Positive End-Expiratory Pressure (PEEP) in people with Acute Respiratory Distress Syndrome (ARDS) and Extracorporeal Membrane Oxygenation, run by University of California, San Diego at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation, Respiratory Failure Patients Treated With ECMO
- What is being tested?
- Personalized Positive End-Expiratory Pressure (PEEP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Jun 2031
- Phase
- Interventional
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
- History of Lung or Cardiac Transplantation, or definite bridge to transplantation
- Patient is not committed to full support
- Treating clinician refusal, or unwillingness to commit to controlled therapeutics (Esophageal Pressure Guided Positive End-Expiratory Pressure and neuromuscular blockade)
- Inability to get informed consent from the patient or legally authorized representative (LAR)
- Patients with contraindications to esophageal balloon placement or inability to successfully place an esophageal balloon will have personalized PEEP determined by electrical impedance tomography.
- 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.
- Severe barotrauma that requires lower mean airway pressure (i.e., PEEP) per the treating physician.
- Patients who are pregnant or prisoners.
- Has been on V-V ECMO > 72 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UC San Diego Health Jacobs Medical Center
La Jolla, California, 92037
About this study
Official title: Personalized Ventilator Settings for Patients on ECMO (PEEPECMO)
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.
Read the detailed description
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.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation, Respiratory Failure Patients Treated With ECMO, Respiratory Failure, ICU, Ventilator Induced Lung Injury
- Being tested
- Personalized Positive End-Expiratory Pressure (PEEP)
- Keywords
- Respiratory failure, ARDS, Acute Respiratory Distress Syndrome, ECMO, Pneumonia, Lung injury, Influenza, COVID, Viruses, Personalized ventilator settings, Positive end expiratory pressure, PEEP
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency, Ventilator-Induced Lung Injury, Pneumonia, Lung Injury, Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Positive End-Expiratory Pressure (PEEP)Device
Also called Esophageal manometry, Titration of PEEP by end-expiratory transpulmonary pressure, Titration of PEEP by electrical impedance tomography (EIT)
The personalized Positive End-Expiratory Pressure (PEEP) will be determined by esophageal manometry or electrical impedance tomography (EIT)
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Ventilator Settings while on ECMO | No intervention | Classic ventilator settings for patients on ECMO. Pressure control, with a respiratory rate of 10, driving pressure of 10, and PEEP of 10. |
| Personalized PEEP | Experimental | Classic ventilator settings for patients on ECMO. Pressure control, with a respiratory rate of 10, driving pressure of 10, and a personalized PEEP (intervention) Receives: Device: Personalized Positive End-Expiratory Pressure (PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker outcome (IL-6)
IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS.
Measured: 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.
Measured: 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.
Measured: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mazen Odish, University of California, San Diego
- Investigators
- Mazen F Odish, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673250
- Sponsor's protocol ID
- 805593
- Other IDs
- 1K23HL181397
- Acronym
- PEEPECMO
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Publications
Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
PubMed 20843245Dianti J, Tisminetzky M, Ferreyro BL, Englesakis M, Del Sorbo L, Sud S, Talmor D, Ball L, Meade M, Hodgson C, Beitler JR, Sahetya S, Nichol A, Fan E, Rochwerg B, Brochard L, Slutsky AS, Ferguson ND, Serpa Neto A, Adhikari NKJ, Angriman F, Goligher EC. Association of Positive End-Expiratory Pressure and Lung Recruitment Selection Strategies with Mortality in Acute Respiratory Distress Syndrome: A Systematic Review and Network Meta-analysis. Am J Respir Crit Care Med. 2022 Jun 1;205(11):1300-1310. doi: 10.1164/rccm.202108-1972OC.
PubMed 35180042Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PubMed 19001507Brodie D, Slutsky AS, Combes A. Extracorporeal Life Support for Adults With Respiratory Failure and Related Indications: A Review. JAMA. 2019 Aug 13;322(6):557-568. doi: 10.1001/jama.2019.9302.
PubMed 31408142Combes A, Hajage D, Capellier G, Demoule A, Lavoue S, Guervilly C, Da Silva D, Zafrani L, Tirot P, Veber B, Maury E, Levy B, Cohen Y, Richard C, Kalfon P, Bouadma L, Mehdaoui H, Beduneau G, Lebreton G, Brochard L, Ferguson ND, Fan E, Slutsky AS, Brodie D, Mercat A; EOLIA Trial Group, REVA, and ECMONet. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975. doi: 10.1056/NEJMoa1800385.
PubMed 29791822Schmidt M, Pham T, Arcadipane A, Agerstrand C, Ohshimo S, Pellegrino V, Vuylsteke A, Guervilly C, McGuinness S, Pierard S, Breeding J, Stewart C, Ching SSW, Camuso JM, Stephens RS, King B, Herr D, Schultz MJ, Neuville M, Zogheib E, Mira JP, Roze H, Pierrot M, Tobin A, Hodgson C, Chevret S, Brodie D, Combes A. Mechanical Ventilation Management during Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome. An International Multicenter Prospective Cohort. Am J Respir Crit Care Med. 2019 Oct 15;200(8):1002-1012. doi: 10.1164/rccm.201806-1094OC.
PubMed 31144997Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
PubMed 30776290Tonna JE, Abrams D, Brodie D, Greenwood JC, Rubio Mateo-Sidron JA, Usman A, Fan E. Management of Adult Patients Supported with Venovenous Extracorporeal Membrane Oxygenation (VV ECMO): Guideline from the Extracorporeal Life Support Organization (ELSO). ASAIO J. 2021 Jun 1;67(6):601-610. doi: 10.1097/MAT.0000000000001432.
PubMed 33965970Lam MTY, Duttke SH, Odish MF, Le HD, Hansen EA, Nguyen CT, Trescott S, Kim R, Deota S, Chang MW, Patel A, Hepokoski M, Alotaibi M, Rolfsen M, Perofsky K, Warden AS, Foley J, Ramirez SI, Dan JM, Abbott RK, Crotty S, Crotty Alexander LE, Malhotra A, Panda S, Benner CW, Coufal NG. Dynamic activity in cis-regulatory elements of leukocytes identifies transcription factor activation and stratifies COVID-19 severity in ICU patients. Cell Rep Med. 2023 Feb 21;4(2):100935. doi: 10.1016/j.xcrm.2023.100935. Epub 2023 Jan 25.
PubMed 36758547Odish MF, Yang J, Cheng G, Yi C, Golts E, Madani M, Pollema T, Owens RL. Treatment of Bronchopleural and Alveolopleural Fistulas in Acute Respiratory Distress Syndrome With Extracorporeal Membrane Oxygenation, a Case Series and Literature Review. Crit Care Explor. 2021 May 14;3(5):e0393. doi: 10.1097/CCE.0000000000000393. eCollection 2021 May.
PubMed 34036268Odish M, Pollema T, Meier A, Hepokoski M, Yi C, Spragg R, Patel HH, Alexander LEC, Sun XS, Jain S, Simonson TS, Malhotra A, Owens RL. Very Low Driving-Pressure Ventilation in Patients With COVID-19 Acute Respiratory Distress Syndrome on Extracorporeal Membrane Oxygenation: A Physiologic Study. J Cardiothorac Vasc Anesth. 2023 Mar;37(3):423-431. doi: 10.1053/j.jvca.2022.11.033. Epub 2022 Nov 28.
PubMed 36567221