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NCT Number: NCT07673250

Personalized Ventilator Settings for Patients on ECMO

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.

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Key information

About this study

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 and sRAGE), oxygenation, decreased dead space, and respiratory mechanics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

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.

  • 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.

Treatment and study plan

Personalized Positive End-Expiratory Pressure (PEEP)

Device

The personalized Positive End-Expiratory Pressure (PEEP) will be determined by esophageal manometry or electrical impedance tomography (EIT)

Other names: Esophageal manometry, Titration of PEEP by end-expiratory transpulmonary pressure, Titration of PEEP by electrical impedance tomography (EIT)

Primary outcomes

  1. Biomarker outcomes (IL-6 and sRAGE)

    Time frame: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment, and end of ECMO run.

    IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS.

    sRAGE is a marker of systemic inflammation and acute lung injury, previously used in studies of ECMO and ARDS.

  2. Respiratory gas exchange (dead space, oxygenation).

    Time frame: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment.

    Arterial oxygenation (mmHg) will be assessed with the arterial blood gas. Deadspace fraction (unitless) will be calculated by the end-title CO2 monitoring.

  3. Respiratory mechanics (compliance of the respiratory system, tidal volume, and imaging)

    Time frame: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, and 72±12 hours post enrollment.

    Compliance (ml/cmH2O) and tidal volumes (milliliters) will be measured by the ventilator. Imaging assessed will be the daily chest x-ray.

Secondary outcomes

  1. Exploratory plasma, urine, and respiratory biomarkers.

    Time frame: Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment, and end of ECMO run.

    Exploratory plasma biomarkers include but are not limited to: angiopoietin-1, angiopoietin-2; chemokind ligand-9, interferon-α; interferon γ-inducible protein-10, tumor necrosis factor α, vascular endothelial growth factor levels, etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Mazen F Odish, M.D.

CONTACT

[email protected]

858-657-7023

Robert L Owens, M.D.

CONTACT

[email protected]

858-657-5258

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Personalized Ventilator Settings for Patients on ECMO (PEEPECMO)

Acronym: PEEPECMO

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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