Novel ECCO2R Device for Hypercapnic Respiratory Failure

A Novel ECCO2R Device as a Lung Protective Measure in Hypercapnic Respiratory Failure: a Prospective Multicenter Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hypercapnic Respiratory Failure
• Intervention / Treatment: Device: Prismalung + treatment

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Stefanie Keiser, Dr. Sc. nat.; Phone Number: +41797956912; Email: stefanie.keiser@usz.ch
• Study Contact Backup: Name: Matthias P Hilty, PD Dr. med.; Phone Number: +41442551111; Email: matthias.hilty@usz.ch

Study Locations

• Switzerland
  • Saint Gallen, Switzerland, 9007
    • Recruiting
    • Kantonsspital St. Gallen
    • Contact: Urs Pietsch, PD MD; Email: urs.pietsch@kssg.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanically ventilated ECCO2R group; Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation	Device: Prismalung + treatment; 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	Device: Prismalung + treatment; Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	Incidence of complications such as bleeding, thrombosis, coagulatory activation as evidences by thrombocytopenia, elevated D-Dimer levels, and plasmatic coagulatory failure.	28 days

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Triemli Hospital, Switzerland; Kantonsspital St. Gallen, St. Gallen, Switzerland; Baxter International Foundation
• Investigators: Principal Investigator: Matthias P Matthias, PD Dr. med., University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypercapnia
• Other Study ID Numbers: BASEC-2021-00912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No