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Patients in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as Extracorporeal Membrane Oxygenation (ECMO). One of the major clinical questions is how to manage the ventilator when patients are on ECMO therapy. Ventilator Induced Lung Injury (VILI) can result from aggressive ventilation of the lung during critical illness. VILI and lung injury such as Acute Respiratory Distress Syndrome (ARDS) can further increase the total body inflammation and stress, this is known as biotrauma. Biotrauma is one of the mechanisms that causes multi-organ failure in critically ill patients. One advantage of ECMO is the ability to greatly reduce the use of the ventilator and thus VILI by taking control of the patient's oxygenation and acid-base status. By minimizing VILI during ECMO we can reduce biotrauma and thus multi-organ failure. Since the optimal ventilator settings for ECMO patients are not known, we plan to study the impact of different ventilator settings during ECMO on patient's physiology and biomarkers of inflammation and injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Driving Pressure Protocol | Experimental | The patients ventilator driving pressure will be decreased (as tolerated by the patient) for 2 hours while on extracorporeal membrane oxygenation (ECMO) support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventilator | Device | The patient starts at a ventilator driving pressure of 10-15 cm of H2O as per guidelines for patients on ECMO with ARDS. The driving pressure is then decreased as tolerated for two hours to evaluate the effects on pulmonary, cardiac, and inflammatory biomarkers. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma IL-6 level from baseline to low driving pressure ventilation | IL-6 is a marker of systemic inflammation, previously used in studies of ECMO and ARDS. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma sRAGE from baseline to low driving pressure ventilation | sRAGE is a marker of systemic inflammation and acute lung injury, previously used in studies of ECMO and ARDS. | 2 hours |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Robert L Owens, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Health | La Jolla | California | 92037-7381 | United States |
Reasonable requests for IPD will be considered by the investigators.
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Single group, intervention
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|
|
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D006333 | Heart Failure |
| D012131 | Respiratory Insufficiency |
| D051437 | Renal Insufficiency |
| D016638 | Critical Illness |
| D008171 | Lung Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055370 | Lung Injury |
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| ID | Term |
|---|---|
| D012122 | Ventilators, Mechanical |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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