Hypercapnic Respiratory Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPrismalung + treatment
Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy
Sponsors
Triemli Hospital, Switzerland
Cantonal Hospital of St. Gallen
Baxter International Foundation
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mechanically ventilated patient: (I) Progressive respiratory failure (pH≤7.25 and/ or PaCO2 ≥9 kPa) during mechanical ventilation (II) with an inability to maintain lung protective ventilation (VT\<4 mL/kg, Ppeak \<30 mbar, Driving Pressure ≤12 mbar) * OR awake spontaneously breathing patient: Respiratory exhaustion (pH≤7.25 and/or PaCO2 ≥9 kPa) * AND Informed Consent as documented by signature
Exclusion criteria
* Mechanical Ventilation group: Need for v-v ECMO * Awake spontaneously breathing group: Need for mechanical ventilation due to inability to remain un-sedated * Thrombocytopenia (\<100G/l) * Contraindications for Heparin therapy (history of heparin antibodies, previous history of intracranial bleeding) * Patients under 18 years of age * Women who are pregnant or breast feeding * Previous enrolment into the current study * Enrolment of the investigator, his/her family members, employees and other dependent persons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Pressure | At timepoint 1 (72 hours) | Peak Pressure (Ppeak \[mbar\]) in mechanically ventilated patients or no intubation in spontaneously breathing patients |
| VV-ECMO therapy | At timepoint 2 (28 days) | No initiation of VV-ECMO therapy |
| Survival | At timepoint 2 (28 days) | Survival |
| Tidal volume | At timepoint 1 (72 hours) | Tidal volume (VT \[mL/kg\]) in mechanically ventilated patients or no intubation in spontaneously breathing patients |
| Driving Pressure | At timepoint 1 (72 hours) | Driving Pressure \[mbar\] in mechanically ventilated patients or no intubation in spontaneously breathing patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoint - complications | 28 days | Incidence of complications such as bleeding, thrombosis, coagulatory activation as evidences by thrombocytopenia, elevated D-Dimer levels, and plasmatic coagulatory failure. |
| Secondary endpoint - respiratory mechanics | 72 hours | Reduction in pulmonary energy load after initiation of ECCO2R as compared to baseline in mechanically ventilated patients |
Countries
Switzerland
Contacts
Primary ContactStefanie Keiser, Dr. Sc. nat.
Backup ContactMatthias P Hilty, PD Dr. med.
Outcome results
None listed