Personalized Ventilator Settings for Patients on ECMO (PEEPECMO)

University of California San Diego

Status: Invitation-only

Conditions: Ventilator Induced Lung Injury; Acute Respiratory Distress Syndrome (ARDS); Extracorporeal Membrane Oxygenation; Respiratory Failure, ICU; Respiratory Failure Patients Treated With ECMO

Treatments: Device: Personalized Positive End-Expiratory Pressure (PEEP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07673250

1K23HL181397 (U.S. NIH Grant/Contract)

805593

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

Standard of Care Ventilator Settings while on ECMO

No Intervention group

Description:

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 group

Description:

Classic ventilator settings for patients on ECMO. Pressure control, with a respiratory rate of 10, driving pressure of 10, and a personalized PEEP (intervention)

Treatment:

Device: Personalized Positive End-Expiratory Pressure (PEEP)