Novel ECCO2R Device for Hypercapnic Respiratory Failure

NCT ID: NCT05316532

Last Updated: 2023-12-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2025-12-31

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.

Conditions

Hypercapnic Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mechanically ventilated ECCO2R group

Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation

Prismalung + treatment

Intervention Type: DEVICE

Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy

Awake spontaneously breathing ECCO2R group

Awake, spontaneously breathing critically ill patients suffering from respiratory exhaustion

Prismalung + treatment

Intervention Type: DEVICE

Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy

Interventions

Prismalung + treatment

Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Triemli Hospital, Switzerland

UNKNOWN

Sponsor Role: collaborator

Kantonsspital St. Gallen, St. Gallen, Switzerland

UNKNOWN

Sponsor Role: collaborator

Baxter International Foundation

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Matthias Hilty

PD Dr. med. Matthias Hilty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthias P Matthias, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Stefanie Keiser, Dr. Sc. nat.

Role: CONTACT

Phone: +41797956912

Email: stefanie.keiser@usz.ch

Matthias P Hilty, PD Dr. med.

Role: CONTACT

Phone: +41442551111

Email: matthias.hilty@usz.ch

Facility Contacts

Urs Pietsch, PD MD

Role: primary

Other Identifiers

BASEC-2021-00912

Identifier Type: -

Identifier Source: org_study_id