Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation, Respiratory Failure, ICU, Respiratory Failure Patients Treated With ECMO, Ventilator Induced Lung Injury
Conditions
Keywords
Respiratory failure, ARDS, Acute Respiratory Distress Syndrome, ECMO, Pneumonia, Lung injury, Influenza, COVID, Viruses, Personalized ventilator settings, Positive end expiratory pressure, PEEP
Brief 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). 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.
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.
Interventions
DEVICEPersonalized Positive End-Expiratory Pressure (PEEP)
The personalized Positive End-Expiratory Pressure (PEEP) will be determined by esophageal manometry or electrical impedance tomography (EIT)
Sponsors
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. History of Lung or Cardiac Transplantation, or definite bridge to transplantation 2. Patient is not committed to full support 3. Treating clinician refusal, or unwillingness to commit to controlled therapeutics (Esophageal Pressure Guided Positive End-Expiratory Pressure and neuromuscular blockade) 4. Inability to get informed consent from the patient or legally authorized representative (LAR) 5. 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. 6. Severe barotrauma that requires lower mean airway pressure (i.e., PEEP) per the treating physician. 7. Patients who are pregnant or prisoners. 8. Has been on V-V ECMO \> 72 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker outcome (IL-6) | Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment. | IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS. |
| Respiratory gas exchange (dead space, oxygenation). | Baseline at enrollment, 24±12 hours post enrollment, 48±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. |
| Respiratory mechanics (compliance of the respiratory system) | Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment. | Compliance (ml/cmH2O) and tidal volumes (milliliters) will be measured by the ventilator. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMazen F Odish, M.D.
University of California, San Diego
Outcome results
None listed