Hypercapnic Respiratory FailureNCT05316532
Novel ECCO2R Device for Hypercapnic Respiratory Failure
An observational study of Hypercapnic Respiratory Failure, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure
- What is being tested?
- Prismalung + treatment
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jun 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen, 9007
Urs Pietsch, PD MD, urs.pietsch@kssg.ch
About this study
Official title: 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.
Read the 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
- Being tested
- Prismalung + treatment
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prismalung + treatmentDevice
Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Mechanically ventilated ECCO2R group | Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation Receives: Device: Prismalung + treatment | |
| Awake spontaneously breathing ECCO2R group | Awake, spontaneously breathing critically ill patients suffering from respiratory exhaustion Receives: Device: Prismalung + treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
Tidal volume (VT [mL/kg]) in mechanically ventilated patients or no intubation in spontaneously breathing patients
Measured: At timepoint 1 (72 hours)
Peak Pressure
Peak Pressure (Ppeak [mbar]) in mechanically ventilated patients or no intubation in spontaneously breathing patients
Measured: At timepoint 1 (72 hours)
Driving Pressure
Driving Pressure [mbar] in mechanically ventilated patients or no intubation in spontaneously breathing patients
Measured: At timepoint 1 (72 hours)
VV-ECMO therapy
No initiation of VV-ECMO therapy
Measured: At timepoint 2 (28 days)
Survival
Survival
Measured: At timepoint 2 (28 days)
Secondary outcomes (2)
Secondary endpoint - respiratory mechanics
Reduction in pulmonary energy load after initiation of ECCO2R as compared to baseline in mechanically ventilated patients
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start5 Jun 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Triemli Hospital, Switzerland, Cantonal Hospital of St. Gallen, Baxter International Foundation
- Responsible party
- Principal investigator, Matthias Hilty, University of Zurich
- Investigators
- Matthias P Matthias, PD Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316532
- Sponsor's protocol ID
- BASEC-2021-00912
- Status last verified
- Dec 2023
- First submitted
- 21 Apr 2021
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel ECCO2R Device as a Lung Protective Measure in Hypercapnic Respiratory Failure: a Prospective Multicenter Trial
- ClinicalTrials.gov ID
- NCT05316532
- Acronym / sponsor ID
- BASEC-2021-00912
- Conditions
- Hypercapnic Respiratory Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Triemli Hospital, Switzerland, Cantonal Hospital of St. Gallen, Baxter International Foundation
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated ECCO2R group | – | Device: Prismalung + treatmentAdult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation |
| Awake spontaneously breathing ECCO2R group | – | Device: Prismalung + treatmentAwake, spontaneously breathing critically ill patients suffering from respiratory exhaustion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prismalung + treatmentLow-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy | Device | Awake spontaneously breathing ECCO2R group, Mechanically ventilated ECCO2R group |
Primary outcome
Tidal volume
Time frame: At timepoint 1 (72 hours)
Tidal volume (VT [mL/kg]) in mechanically ventilated patients or no intubation in spontaneously breathing patients
Peak Pressure
Time frame: At timepoint 1 (72 hours)
Peak Pressure (Ppeak [mbar]) in mechanically ventilated patients or no intubation in spontaneously breathing patients
Driving Pressure
Time frame: At timepoint 1 (72 hours)
Driving Pressure [mbar] in mechanically ventilated patients or no intubation in spontaneously breathing patients
VV-ECMO therapy
Time frame: At timepoint 2 (28 days)
No initiation of VV-ECMO therapy
Survival
Time frame: At timepoint 2 (28 days)
Survival
2 secondary outcomes
Secondary endpoint - respiratory mechanics
Time frame: 72 hours
Secondary endpoint - complications
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias P Matthias, PD Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercapnic Respiratory Failure, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Keiser, Dr. Sc. nat. (+41797956912, stefanie.keiser@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (time frame: At timepoint 1 (72 hours)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.