UC San Diego Health Jacobs Medical Center
La Jolla, California, 92037, United States
Location contact
Mazen F Odish, M.D.
CONTACT
Robert L Owens, M.D.
CONTACT
NCT Number: NCT07673250
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
La Jolla, California, 92037, United States
Mazen F Odish, M.D.
CONTACT
Robert L Owens, M.D.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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)
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Mazen F Odish, M.D.
CONTACT
Robert L Owens, M.D.
CONTACT
University of California, San Diego
Other
Personalized Ventilator Settings for Patients on ECMO (PEEPECMO)
Acronym: PEEPECMO
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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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