Novel ECCO2R Device for Hypercapnic Respiratory Failure

Recruiting

• Conditions: Hypercapnic Respiratory Failure
• Interventions: Device: Prismalung + treatment

• Registration Number: NCT05316532
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2023-06-05
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-28
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanically ventilated ECCO2R group	Prismalung + treatment	Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation
Awake spontaneously breathing ECCO2R group	Prismalung + treatment	Awake, spontaneously breathing critically ill patients suffering from respiratory exhaustion

Primary Outcome Measures

Name	Time	Method
Driving Pressure	At timepoint 1 (72 hours)	Driving Pressure \[mbar\] in mechanically ventilated patients or no intubation in spontaneously breathing patients
Survival	At timepoint 2 (28 days)	Survival
VV-ECMO therapy	At timepoint 2 (28 days)	No initiation of VV-ECMO therapy
Tidal volume	At timepoint 1 (72 hours)	Tidal volume (VT \[mL/kg\]) in mechanically ventilated patients or no intubation in spontaneously breathing patients
Peak Pressure	At timepoint 1 (72 hours)	Peak Pressure (Ppeak \[mbar\]) in mechanically ventilated patients or no intubation in spontaneously breathing patients

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint - respiratory mechanics	72 hours	Reduction in pulmonary energy load after initiation of ECCO2R as compared to baseline in mechanically ventilated patients
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.

Trial Locations

Locations (1)

Kantonsspital St. Gallen; 🇨🇭 Saint Gallen, Switzerland