Status:
UNKNOWN
Novel ECCO2R Device for Hypercapnic Respiratory Failure
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Triemli Hospital, Switzerland
Cantonal Hospital of St. Gallen
Conditions:
Hypercapnic Respiratory Failure
Eligibility:
All Genders
18+ years
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 ...
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 pressu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 5 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05316532
Start Date
June 5 2023
End Date
December 31 2025
Last Update
December 28 2023
Active Locations (1)
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1
Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9007