Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT02259335
Status:
UNKNOWN
Last Update Posted:
2016-10-11
First Post:
2014-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-08', 'studyFirstSubmitDate': '2014-10-04', 'studyFirstSubmitQcDate': '2014-10-07', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'passing a weaning trial using a T-piece method', 'timeFrame': '1 hour', 'description': 'avoiding to reach the criteria of weaning failure'}, {'measure': 'weaning success', 'timeFrame': '48 hours', 'description': 'avoiding reintubation after removal of DeCap'}], 'secondaryOutcomes': [{'measure': 'Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['weaning from mechanical ventilation', 'extracorporeal CO2 removal', 'post-extubation failure'], 'conditions': ['Patients With Acute Hypercapnic Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Weaning from invasive mechanical ventilation is one of the major clinical problem especially ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.\n\nThe aim of this pilot feasibility and safety trial is to assess the possibility of shorten the duration of mechanical ventilation using a device able to remove CO2 and theoretically able to allow therefore the praecox extubation', 'detailedDescription': 'Weaning from invasive mechanical ventilation is one of the major clinical problem especially ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania. Up to 60% of the ventilatory time is devoted in these patients to the process of weaning.\n\nThese patients very often fail several weaning attempt, when a T-piece trial method is used. In this case they are also very likely to require tracheotomy.\n\nIn this study we will enroll those still hypercapnic patients fitting the criteria of readiness to be wean (i.e. clinical stability, normal sensorium and good cough reflex) and failing a T-piece trail because of a rise in PaCO2 (\\>20% from baseline) and/or a rapid shallow breathing index (f/VT)\\> 100.\n\nAfter the unsuccessful trial they will be reconnected to the ventilator and they will repeat hours later the same T-piece trial once the extracorporeal CO2 removal device (DeCap) will be connected via a double lumen catheter in the femoral vein.\n\nThe investigators aim to verify whether using the DeCap) the investigators will be able to avoid at the end of the T-piece trial the criteria of failure. If so, the patient will be extubated and DeCap will be continued when all of the following were achieved for at least 12 hours: respiratory rate less than 25 breaths/min; pH greater than 7.35; Paco2 less than 20% of the baseline value; and absence of use of the accessory muscles or paradoxical abdominal movements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients meeting the criteria for readiness to be weaned (i.e. clinical stability, FiO2\\<50%, normal sensorium, body temperature \\< 38 and satisfactory cough reflex)\n* Failing a T-piece trial after 1 hour or before for a rise in PaCO2\\>20% from baseline and with f/VT ratio \\>100\n\nExclusion Criteria:\n\n* Patients NOT meeting the criteria for readiness to be weaned\n* Patients succeeding a T-piece trial'}, 'identificationModule': {'nctId': 'NCT02259335', 'acronym': 'WeanPRO', 'briefTitle': 'Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'A Pilot Study on the Use of Extracorporeal CO2 Removal During the Weaning Process From Mechanical Ventilation', 'orgStudyIdInfo': {'id': '110/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients under invasive ventilation', 'description': 'those patients failing a T-piece trial beacuse of a PaCO2 rise\\>20% of baseline and/or a rapid shallow-breathing index \\>100 will be reconnected to the ventilator Two hours later they will repeat a T-piece trial after connection to the CO2 removal device', 'interventionNames': ['Device: Extracorporeal CO2 removal device']}], 'interventions': [{'name': 'Extracorporeal CO2 removal device', 'type': 'DEVICE', 'otherNames': ['DeCap'], 'description': 'A device able to remove CO2 using a dedicated device connected to the patient via a double lumen catheter inserted in the femoral vein', 'armGroupLabels': ['patients under invasive ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Turin', 'state': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco V Ranieri, MD', 'role': 'CONTACT', 'email': 'marco.ranieri@unito.it', 'phone': '011633', 'phoneExt': '5500'}, {'name': 'Vito Fanelli, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Città della Salute e della Scienza di Torino, Molinette Hospital', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '40138', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Nava, MD', 'role': 'CONTACT', 'email': 'stefano.nava@aosp.bo.it', 'phone': '051 6364017'}, {'name': 'Stefano Nava, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lara Pisani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luca Fasano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nadia Corcione, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "San'Orsola Malpighi Hospital, Bologna ITALY", 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Turin, Italy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Respiratory Medicine', 'investigatorFullName': 'dr. Stefano Nava', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}