Novel ECCO2R Device for Hypercapnic Respiratory Failure

Hypercapnic Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316532
• Other study ID #: BASEC-2021-00912
• Status: Recruiting
• Start date: June 5, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: University of Zurich
• Contact: Stefanie Keiser, Dr. Sc. nat.
• Phone: +41797956912
• Email: stefanie.keiser[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercapnia
• Hypercapnic Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Prismalung + treatment
Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy

Locations

Country	Name	City	State
Switzerland	Kantonsspital St. Gallen	Saint Gallen

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Baxter International Foundation, Kantonsspital St. Gallen, St. Gallen, Switzerland, Triemli Hospital, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tidal volume	Tidal volume (VT [mL/kg]) in mechanically ventilated patients or no intubation in spontaneously breathing patients	At timepoint 1 (72 hours)
Primary	Peak Pressure	Peak Pressure (Ppeak [mbar]) in mechanically ventilated patients or no intubation in spontaneously breathing patients	At timepoint 1 (72 hours)
Primary	Driving Pressure	Driving Pressure [mbar] in mechanically ventilated patients or no intubation in spontaneously breathing patients	At timepoint 1 (72 hours)
Primary	VV-ECMO therapy	No initiation of VV-ECMO therapy	At timepoint 2 (28 days)
Primary	Survival	Survival	At timepoint 2 (28 days)
Secondary	Secondary endpoint - respiratory mechanics	Reduction in pulmonary energy load after initiation of ECCO2R as compared to baseline in mechanically ventilated patients	72 hours
Secondary	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