Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2026-01-10 @ 9:42 PM
Study NCT ID:
NCT01877850
Status:
COMPLETED
Last Update Posted:
2015-04-23
First Post:
2013-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utility of a Weaning Protocol in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-22', 'studyFirstSubmitDate': '2013-06-01', 'studyFirstSubmitQcDate': '2013-06-11', 'lastUpdatePostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': 'within the first 26 days (plus or minus 22 days) after ICU recovery'}, {'measure': 'success of weaning', 'timeFrame': 'spontaneous breathing for 48 hours'}], 'primaryOutcomes': [{'measure': 'duration of weaning', 'timeFrame': 'within the first 15 days (plus or minus 5 days) after start of weaning'}], 'secondaryOutcomes': [{'measure': 'duration of mechanical ventilation', 'timeFrame': 'within the first 12 days (plus or minus 10 days) after start of mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Weaning Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the difference of the duration of weaning process from the ventilator between protocol-driven weaned patients and clinical judgment driven weaned patients.', 'detailedDescription': 'All patients with prolonged weaning and who required tracheostomy are enrolled in the study. These patients are randomized as "Case or Control" by a computer program.\n\nPatients can start the weaning process when the acute phase of the respiratory failure has been resolved and pressure support ventilation was setted.\n\nFor all this patients are calculated modified-BWAP(BWAP-M) and TOBIN indexes. The "Case" patients started the weaning protocol process only if BWAP-M value is more than 15 or BWAP-M 10-15 with Tobin index \\< 100.\n\nIf not, the BWAP-M and Tobin will be calculated every day. The Control patients will start weaning by clinical judgement even if the BWAP-M value is less than 10.\n\nFor all patients are calculated: the duration of weaning process, the ICU length of stay and the duration of the mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'difficult to wean patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. all patients that are clinically identified as prolonged to wean (failed 3 spontaneous breathing trials or 7 days or more of mechanical ventilation after the initial unsuccessful trial) and tracheostomized in ICU\n2. improvement or resolution of the underlying causes of acute respiratory failure ratio between pressure partial artery of oxygen and fraction inspired oxygen (PaO2/FiO2) \\>200 with fraction inspired oxygen (FiO2)\\< 0,45.\n3. pressure supported ventilation at the time of enrollment.\n\nExclusion Criteria:\n\n1. patients assessed as easy weaning and not tracheostomized;\n2. patients already tracheostomized on admission to ICU.'}, 'identificationModule': {'nctId': 'NCT01877850', 'acronym': 'WEAN', 'briefTitle': 'Utility of a Weaning Protocol in ICU', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Brescia'}, 'officialTitle': 'Non Pharmacological Randomized Clinical Trial Designed to Evaluate the Difference of the Duration of Weaning Process From the Ventilator Between Protocol-driven Weaned Patients and Clinical-driven Weaned Patients.', 'orgStudyIdInfo': {'id': 'NPn1351'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'case', 'description': 'patients with BPAW-M more than 15 or between 10 and 15, but with Tobin \\<100 will be weaned with the weaning protocol by nurses', 'interventionNames': ['Procedure: weaning protocol']}, {'label': 'control', 'description': 'patients with any BWAP-M will be weaned by clinical judgment of physicians'}], 'interventions': [{'name': 'weaning protocol', 'type': 'PROCEDURE', 'description': 'Reduction of pressure support ventilation (PSV) by 2cmH2O at a time to a maximum of 4cmH2O per day.\n\nWhen a patient was able to tolerate PSV less than 8 cmH2O for at least 120 minutes, the nurses started to reduce End Expiratory Positive Pressure (PEEP) by 2cmH2O at a time to a maximum of 4cmH2O per day.\n\nWhen a patient was able to tolerate PSV less than 8 cmH2O with PEEP less than 6 cmH2O, the nurses started SBT trial: Continuos Positive Pressure Airways of 6cmH2O for at least 120 minutes and following discontinuation from ventilator.', 'armGroupLabels': ['case']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25128', 'city': 'Brescia', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Institute of Anesthesiology and Intensive Care of the University of Brescia, Spedali Civili, Italy,', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'overallOfficials': [{'name': 'Elena Peli', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ELENA PELI,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'dirigente medico', 'investigatorFullName': 'ELENA PELI,MD', 'investigatorAffiliation': 'Università degli Studi di Brescia'}}}}