Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
Study NCT ID:
NCT04323150
Status:
COMPLETED
Last Update Posted:
2022-04-08
First Post:
2020-03-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D000081084', 'term': 'Accidental Injuries'}, {'id': 'D012640', 'term': 'Seizures'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-07', 'studyFirstSubmitDate': '2020-03-21', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of the ventilator - associated pneumoniae (VAP)', 'timeFrame': 'Change from Baseline CPIS at 96 hours', 'description': 'Assessment of CPIS, if CPIS equal or more 6 points VAP will be observed'}, {'measure': 'Contamination of closet inanimate surfaces', 'timeFrame': 'Change from Baseline Microbiology researching at 96 hours', 'description': 'Microbiology researching samples from circuit of a respirator and a bed'}], 'secondaryOutcomes': [{'measure': 'Organ dysfunction', 'timeFrame': 'Change from Baseline SOFA at 96 hours', 'description': 'Patient examination with Sequential Organ Function Assessment (SOFA)'}, {'measure': 'Mortality', 'timeFrame': '28 days', 'description': 'Mortality for 28 days of a hospitalization'}, {'measure': 'C - reactive protein', 'timeFrame': 'Change from Baseline CRP researching at 96 hours', 'description': 'Investigation of a Biomarker of the VAP'}, {'measure': 'Procalcitonin', 'timeFrame': 'Change from Baseline CRP researching at 96 hours', 'description': 'Investigation of a Biomarker of the VAP'}, {'measure': 'sTREM 1', 'timeFrame': 'Change from Baseline CRP researching at 96 hours', 'description': 'Investigation of a Biomarker of the VAP'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Traumatic Brain Injury', 'Pancreatic Diseases', 'Trauma Injury', 'Seizures', 'Encephalitis', 'Abdominal Sepsis']}, 'descriptionModule': {'briefSummary': 'The investigators are suggesting that closed suction systems may reduce the risk of the ventilator - associated pneumoniae (VAP) and the contamination of the closest unanimated surfaces. In 2011 David et al. have shown that closed suction systems might reduce the incidence of the late VAP. Research team is thinking that preventive bundle with closed suction systems can prevent to onset of the VAP. All enrolled patients is randomizing into two groups: control group - conventional suctioning and research group - suctioning with closed suction system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* invasive mechanical ventilation beyond 48 hours\n\nExclusion Criteria:\n\n* hospital - acquired pneumonia\n* community - acquired pneumoniae\n* BMI \\> 35 kg/cm2\n* pregnancy\n* tracheostomy'}, 'identificationModule': {'nctId': 'NCT04323150', 'acronym': 'CSS-VAP', 'briefTitle': 'The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia.', 'organization': {'class': 'OTHER', 'fullName': 'Northern State Medical University'}, 'officialTitle': 'The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia, Respiratory-associated Microbiome and Contamination of Inanimate Surfaces: a Pilot Study.', 'orgStudyIdInfo': {'id': 'CSS-VAP-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Closed suction systems', 'interventionNames': ['Device: Closed suction systems']}, {'type': 'OTHER', 'label': 'Open (conventional) suction', 'description': 'control group', 'interventionNames': ['Device: Conventional suction system']}], 'interventions': [{'name': 'Closed suction systems', 'type': 'DEVICE', 'description': 'Closed suction systems are using for prevention of the ventilator-associated pneumoniae', 'armGroupLabels': ['Closed suction systems']}, {'name': 'Conventional suction system', 'type': 'DEVICE', 'description': 'The using of open (conventional) suctioning', 'armGroupLabels': ['Open (conventional) suction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '164522', 'city': 'Severodvinsk', 'country': 'Russia', 'facility': 'State Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"', 'geoPoint': {'lat': 64.55825, 'lon': 39.82971}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'All IPD that underlie results in a publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of the Department of Anaesthesiology and Intensive Care Medicine, MD, PhD', 'investigatorFullName': 'Vsevolod V. Kuzkov', 'investigatorAffiliation': 'Northern State Medical University'}}}}