Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT02714751
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2016-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Informative Intervention to the ICU Team About the Presence of Asynchronies in Mechanically Ventilated Patients: Effect Over Incidence Reduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2016-03-16', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of asynchronies', 'timeFrame': 'one year'}]}, 'conditionsModule': {'conditions': ['Asynchronies']}, 'descriptionModule': {'briefSummary': 'Mechanical ventilation (MV) if a life-support treatment for critically ill patients that can develop adverse effects. Patient-ventilator asynchronies can be present from the beginning of MV, it can be associated with poor outcome and it can develop clinical changes. The aim of this study is to evaluate if the knowledge of the presence of asynchronies by the healthcare team can help to reduce its incidence, improving outcomes of critically ill patients.\n\nA prospective, single-center, before and after study will be conducted in the ICU of Hospital de Sabadell. The study will have 2 phases: a first observational period where the incidence of asynchronies will be assessed, and a second period where a daily information of the presence of asynchronies to the healthcare team will be done with the aim to reduce the incidence.\n\nA continous record of asynchronies and clinical variables will be done during ICU stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Invasive mechanical ventilation \\< 24 hours.\n* \\> 18 years-old\n\nExclusion Criteria:\n\n* \\> 24 hours of invasive mechanical ventilation at admission.\n* \\<48 hours of data collected\n* Informed consent not obtained'}, 'identificationModule': {'nctId': 'NCT02714751', 'briefTitle': 'Evaluation of an Informative Intervention to the ICU Team About the Presence of Asynchronies in Mechanically Ventilated Patients: Effect Over Incidence Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'orgStudyIdInfo': {'id': 'CIR2015/057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Observational group'}, {'type': 'OTHER', 'label': 'Group after information intervention', 'description': 'Control group after daily information to healthcare team', 'interventionNames': ['Behavioral: Daily asynchronies information']}], 'interventions': [{'name': 'Daily asynchronies information', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Group after information intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sabadell', 'country': 'Spain', 'facility': 'Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Lluis Blanch', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}