Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-30 @ 11:25 PM
Study NCT ID:
NCT05316532
Status:
RECRUITING
Last Update Posted:
2023-12-28
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel ECCO2R Device for Hypercapnic Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tidal volume', 'timeFrame': 'At timepoint 1 (72 hours)', 'description': 'Tidal volume (VT \\[mL/kg\\]) in mechanically ventilated patients or no intubation in spontaneously breathing patients'}, {'measure': 'Peak Pressure', 'timeFrame': 'At timepoint 1 (72 hours)', 'description': 'Peak Pressure (Ppeak \\[mbar\\]) in mechanically ventilated patients or no intubation in spontaneously breathing patients'}, {'measure': 'Driving Pressure', 'timeFrame': 'At timepoint 1 (72 hours)', 'description': 'Driving Pressure \\[mbar\\] in mechanically ventilated patients or no intubation in spontaneously breathing patients'}, {'measure': 'VV-ECMO therapy', 'timeFrame': 'At timepoint 2 (28 days)', 'description': 'No initiation of VV-ECMO therapy'}, {'measure': 'Survival', 'timeFrame': 'At timepoint 2 (28 days)', 'description': 'Survival'}], 'secondaryOutcomes': [{'measure': 'Secondary endpoint - respiratory mechanics', 'timeFrame': '72 hours', 'description': 'Reduction in pulmonary energy load after initiation of ECCO2R as compared to baseline in mechanically ventilated patients'}, {'measure': 'Secondary endpoint - complications', 'timeFrame': '28 days', 'description': 'Incidence of complications such as bleeding, thrombosis, coagulatory activation as evidences by thrombocytopenia, elevated D-Dimer levels, and plasmatic coagulatory failure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercapnic Respiratory Failure']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* OR awake spontaneously breathing patient: Respiratory exhaustion (pH≤7.25 and/or PaCO2 ≥9 kPa)\n* AND Informed Consent as documented by signature\n\nExclusion Criteria:\n\n* Mechanical Ventilation group: Need for v-v ECMO\n* Awake spontaneously breathing group: Need for mechanical ventilation due to inability to remain un-sedated\n* Thrombocytopenia (\\<100G/l)\n* Contraindications for Heparin therapy (history of heparin antibodies, previous history of intracranial bleeding)\n* Patients under 18 years of age\n* Women who are pregnant or breast feeding\n* Previous enrolment into the current study\n* Enrolment of the investigator, his/her family members, employees and other dependent persons'}, 'identificationModule': {'nctId': 'NCT05316532', 'briefTitle': 'Novel ECCO2R Device for Hypercapnic Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'A Novel ECCO2R Device as a Lung Protective Measure in Hypercapnic Respiratory Failure: a Prospective Multicenter Trial', 'orgStudyIdInfo': {'id': 'BASEC-2021-00912'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mechanically ventilated ECCO2R group', 'description': 'Adult, mechanically ventilated critically ill patients with respiratory failure and incapacity to sustain lung protective ventilation', 'interventionNames': ['Device: Prismalung + treatment']}, {'label': 'Awake spontaneously breathing ECCO2R group', 'description': 'Awake, spontaneously breathing critically ill patients suffering from respiratory exhaustion', 'interventionNames': ['Device: Prismalung + treatment']}], 'interventions': [{'name': 'Prismalung + treatment', 'type': 'DEVICE', 'description': 'Low-flow extracorporeal CO2 removal with or without concurrent continuous renal replacement therapy', 'armGroupLabels': ['Awake spontaneously breathing ECCO2R group', 'Mechanically ventilated ECCO2R group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Urs Pietsch, PD MD', 'role': 'CONTACT', 'email': 'urs.pietsch@kssg.ch'}], 'facility': 'Kantonsspital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'centralContacts': [{'name': 'Stefanie Keiser, Dr. Sc. nat.', 'role': 'CONTACT', 'email': 'stefanie.keiser@usz.ch', 'phone': '+41797956912'}, {'name': 'Matthias P Hilty, PD Dr. med.', 'role': 'CONTACT', 'email': 'matthias.hilty@usz.ch', 'phone': '+41442551111'}], 'overallOfficials': [{'name': 'Matthias P Matthias, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Triemli Hospital, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Kantonsspital St. Gallen, St. Gallen, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Baxter International Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. Matthias Hilty', 'investigatorFullName': 'Matthias Hilty', 'investigatorAffiliation': 'University of Zurich'}}}}