Health TrialsbyHealthPanel

Personalized Ventilator Settings for Patients on ECMO

ConditionsAcute Respiratory Distress Syndrome (ARDS)Extracorporeal Membrane OxygenationRespiratory Failure Patients Treated With ECMORespiratory Failure, ICUVentilator Induced Lung Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Standard of Care Ventilator Settings while on ECMONo intervention 0 interventions
Group B: Personalized PEEPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Biomarker outcomes (IL-6 and sRAGE)

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, and end of ECMO run.
2

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.

Time frame
Baseline at enrollment, 24±12 hours post enrollment, 48±12 hours post enrollment, 72±12 hours post enrollment.
3

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

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, and 72±12 hours post enrollment.

Secondary outcomes

1

Exploratory plasma, urine, and respiratory biomarkers.

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.

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: