Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-02-06 @ 6:44 AM
Study NCT ID:
NCT03111303
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2017-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanical Ventilation Parameters in HAP Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2654}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inspiratory pressure', 'timeFrame': 'during MV', 'description': 'most high inspiratory pressure during MV'}, {'measure': 'Positive end expiratory pressure (PEEP)', 'timeFrame': 'during MV', 'description': 'most high PEEP during MV'}], 'primaryOutcomes': [{'measure': 'length of mechanical ventilation', 'timeFrame': 'during MV', 'description': 'days of MV'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': '1 month', 'description': 'length of stay in ICU'}, {'measure': 'Hospital length of stay (LOS)', 'timeFrame': '1 month', 'description': 'length of hospital stay'}, {'measure': 'Mortality', 'timeFrame': '1 month', 'description': 'mortality during Hospital LOS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation Pressure High']}, 'descriptionModule': {'briefSummary': 'Hospital-acquired pneumonia (HAP) in patients in intensive care often requires the mechanical ventilation (MV). Management and weaning from MV are given by specificity of this type of pulmonary inflammation. Enrolled in the retrospective, observational study were all patients older than 18 years staying at the ICU of University Hospital in Olomouc, between 1 January 2011 and 31 December 2016. The determination of the parameters of the MV, ICU length of stay, hospital length of stay and mortality in HAP group were compared with the control group of patients without HAP.', 'detailedDescription': 'Hospital-acquired pneumonia (HAP) development influences the parameters of mechanical ventilation, intensive care unit (ICU) length of stay, hospital length of stay, need of tracheostomy, bronchoscopy, reconnection to MV and mortality. We respect HAP definition: acute inflammation of the respiratory bronchioles, alveolar structures and pulmonary interstitium. Clinically it is defined as the presence of newly developed or progressive infiltrates on chest radiographs plus at least two other signs of respiratory tract infection: temperature \\>38 °C, chest pain, purulent sputum, leukocytosis or leukopenia, signs of inflammation on auscultation, cough and/or respiratory insufficiency. HAP is defined as pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission. A retrospective, observational study processing data on all consecutive intensive care patients older than 18 years of age between 1 January 2011 and 31 December 2015. The aim was to determine the incidence of potential risk factors and their impact on the development of HAP. The primary outcome was investigation of the relationship between mechanical ventilation parameters and the presence of early- and late-onset HAP. Enrolled in the study were patients staying at the ICU of the Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, between 1 January 2011 and 31 December 2016. The participants were all patients older than 18 years of age consecutively admitted to the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Enrolled in the study were patients staying at the ICU of the Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, between 1 January 2011 and 31 December 2015. The participants were all patients older than 18 years of age consecutively admitted to the ICU, who met HAP criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+\n* Need of Mechanical ventilation (Pressure controlled mechanical ventilation or Pressure support ventilation)\n\nExclusion Criteria:\n\n* Organ donor\n* Need Volume controlled mechanical ventilation\n* no mechanical ventilation'}, 'identificationModule': {'nctId': 'NCT03111303', 'briefTitle': 'Mechanical Ventilation Parameters in HAP Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Olomouc'}, 'officialTitle': 'Nosocomial Pneumonia as a Factor Influencing Parameters of Mechanical Ventilation: Results of a Retrospective, Observational Study', 'orgStudyIdInfo': {'id': '65/16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HAP patients', 'description': 'Mechanical ventilation, patients fulfilled HAP criteria', 'interventionNames': ['Device: mechanical ventilation']}, {'label': 'non HAP patients', 'description': 'Mechanical ventilation, patients without HAP', 'interventionNames': ['Device: mechanical ventilation']}], 'interventions': [{'name': 'mechanical ventilation', 'type': 'DEVICE', 'description': 'Connection to mechanical ventilator', 'armGroupLabels': ['HAP patients', 'non HAP patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Radovan Uvizl', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UH Olomouc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Olomouc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D.', 'investigatorFullName': 'Radovan Uvizl', 'investigatorAffiliation': 'University Hospital Olomouc'}}}}