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| Name | Class |
|---|---|
| Triemli Hospital, Switzerland | UNKNOWN |
| Cantonal Hospital of St. Gallen | OTHER |
| Baxter International Foundation | UNKNOWN |
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The objective of this study is to assess the efficacy and safety of this new Prismalung+ membrane in its intended clinical setting by demonstrating a reduction in ventilatory parameters and pulmonary energy load or the successful maintenance of spontaneous breathing, respectively, the absence of the need to initiate vv-ECMO therapy, and initial survival.
Our hypotheses are that decarboxylation therapy by means of the novel Prismalung+ membrane in patients with hypercapnic respiratory failure (I) allows the reduction of tidal volume, peak airway pressure, dP and pulmonary energy load (as measured by AUC over 72 hours) as compared to baseline in mechanically ventilated patients OR is associated with successful continuation of spontaneous breathing despite respiratory exhaustion (no decision to intubate), and that these patients (II) warrant no decision to initiate vv-ECMO therapy and (III) do not experience early mortality.
The primary Objectives of the study are to test our hypotheses I to III by applying the novel Prismalung+ ECCO2R device in mechanically ventilated patients and spontaneously breathing patients experiencing hypercapnic respiratory failure in a multi-central prospective trial in three experienced intensive care units in Switzerland.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanically ventilated ECCO2R group | Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation |
| |
| Awake spontaneously breathing ECCO2R group | Awake, spontaneously breathing critically ill patients suffering from respiratory exhaustion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prismalung + treatment | Device | Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tidal volume | Tidal volume (VT [mL/kg]) in mechanically ventilated patients or no intubation in spontaneously breathing patients | At timepoint 1 (72 hours) |
| Peak Pressure | Peak Pressure (Ppeak [mbar]) in mechanically ventilated patients or no intubation in spontaneously breathing patients | At timepoint 1 (72 hours) |
| Driving Pressure | Driving Pressure [mbar] in mechanically ventilated patients or no intubation in spontaneously breathing patients | At timepoint 1 (72 hours) |
| VV-ECMO therapy | No initiation of VV-ECMO therapy | At timepoint 2 (28 days) |
| Survival | Survival | At timepoint 2 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoint - respiratory mechanics | Reduction in pulmonary energy load after initiation of ECCO2R as compared to baseline in mechanically ventilated patients | 72 hours |
| Secondary endpoint - complications |
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Inclusion Criteria:
Exclusion Criteria:
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Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation or respiratory exhausting awake, spontaneously breathing critically ill patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefanie Keiser, Dr. Sc. nat. | Contact | +41797956912 | stefanie.keiser@usz.ch | |
| Matthias P Hilty, PD Dr. med. | Contact | +41442551111 | matthias.hilty@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Matthias P Matthias, PD Dr. med. | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital St. Gallen | Recruiting | Sankt Gallen | 9007 | Switzerland |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Incidence of complications such as bleeding, thrombosis, coagulatory activation as evidences by thrombocytopenia, elevated D-Dimer levels, and plasmatic coagulatory failure.
| 28 days |