Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-04 @ 8:27 PM
Study NCT ID:
NCT03763695
Status:
UNKNOWN
Last Update Posted:
2018-12-04
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a VAP Prevention Bundle in the PICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-01', 'studyFirstSubmitDate': '2018-09-18', 'studyFirstSubmitQcDate': '2018-12-01', 'lastUpdatePostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAP incidence', 'timeFrame': 'From 48 hours after intubation to 48 hours after extubation', 'description': 'Incidence of VAP in pediatric patients intubated for more than 48 hours'}], 'secondaryOutcomes': [{'measure': 'Prevalence of orotracheal bacterial colonization in ventilated patients', 'timeFrame': 'From 48 hours after intubation to 48 hours after extubation', 'description': 'Evaluation of orotracheal bacterial colonization in pediatric patients undergoing mechanical ventilation twice a week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric intensive care unit', 'Oral Hygiene Care', 'Chlorhexidine', 'Broncho-alveolar lavage', 'Pharyngeal swab'], 'conditions': ['Ventilator Associated Pneumonia']}, 'descriptionModule': {'briefSummary': 'This observational monocentric prospective study aims to evaluate the efficacy of new measures for ventilator associated pneumonia (VAP) management in the pediatric population in the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8 beds. The investigators will compare the incidence of VAP in the group of patients in which this protocol has been implemented to a retrospective control group of patients before the new protocol implementation. VAP bundle includes oral care hygiene measures (i.e chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45 degrees.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients admitted to our ICU requiring mechanical ventilation for more than 48 hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\< 18 years\n* patients receiving mechanical ventilation for more than 48 hours\n\nExclusion Criteria:\n\n* no informed consent\n* pregnancy\n* previous endotracheal antibiotic therapy'}, 'identificationModule': {'nctId': 'NCT03763695', 'briefTitle': 'Effectiveness of a VAP Prevention Bundle in the PICU', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Effectiveness of a Bundle of Ventilator Associated Pneumonia (VAP) Prevention in the Pediatric Intensive Care Unit (PICU): an Observational Study', 'orgStudyIdInfo': {'id': '1855'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective control group', 'description': 'Patients admitted in our PICU before the implementation of the protocol for VAP prevention (from 01/01/2016 to 12/31/2017)', 'interventionNames': ['Other: Evaluation of VAP incidence before the protocol introduction']}, {'label': 'Prospective group', 'description': 'Patients admitted to our PICU since the VAP bundle has been introduced in the clinical practice (from 01/01/2018)', 'interventionNames': ['Other: Measures for the VAP prevention in the PICU']}], 'interventions': [{'name': 'Measures for the VAP prevention in the PICU', 'type': 'OTHER', 'description': 'Oral hygiene care (i.e chlorhexidine swab); clean and dry ventilator circuits; head positioning at 45 degrees.', 'armGroupLabels': ['Prospective group']}, {'name': 'Evaluation of VAP incidence before the protocol introduction', 'type': 'OTHER', 'description': 'evaluation of VAP incidence in our pediatric population of intensive care patients before the implementation of the protocol for VAP prevention', 'armGroupLabels': ['Retrospective control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'state': 'RM', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Orazio Genovese, MD', 'role': 'CONTACT'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Orazio Genovese, MD', 'role': 'CONTACT', 'email': 'orazio.genovese@policlinicogemelli.it', 'phone': '0630153125'}], 'overallOfficials': [{'name': 'Giorgio Conti, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Agostino Gemelli; IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ilaria Vitali', 'class': 'UNKNOWN'}, {'name': 'Antonio Maria Dell Anna', 'class': 'UNKNOWN'}, {'name': 'Leonardo Dassatti', 'class': 'UNKNOWN'}, {'name': 'Giuseppe Bello', 'class': 'UNKNOWN'}, {'name': 'Giorgio Conti', 'class': 'UNKNOWN'}, {'name': 'Antonio D Addona', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, pediatric intensive care unit', 'investigatorFullName': 'Orazio Genovese', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}