Novel ECCO2R Device for Hypercapnic Respiratory Failure

NCT05316532 | Unknown DMC

• 1 other identifier: BASEC-2021-00912
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercapnic Respiratory Failure

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Secondary endpoint - respiratory mechanics

  72 hours

• Secondary endpoint - complications

  28 days

Study Arms (2)

Mechanically ventilated ECCO2R group

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

Device: Prismalung + treatment

Awake spontaneously breathing ECCO2R group

Awake, spontaneously breathing critically ill patients suffering from respiratory exhaustion

Device: Prismalung + treatment

Interventions

Prismalung + treatment DEVICE

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

Awake spontaneously breathing ECCO2R group; Mechanically ventilated ECCO2R group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Triemli Hospital, Switzerland: collaborator
• Cantonal Hospital of St. Gallen: collaborator
• Baxter International Foundation: collaborator

Study Sites (1)

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Matthias P Matthias, PD Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie Keiser, Dr. Sc. nat.

CONTACT

+41797956912; stefanie.keiser@usz.ch

Matthias P Hilty, PD Dr. med.

CONTACT

+41442551111; matthias.hilty@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Matthias Hilty

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 7, 2022
• Study Start: June 5, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

CH (1)