Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT01134133
Status:
WITHDRAWN
Last Update Posted:
2011-06-23
First Post:
2010-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'whyStopped': 'Slow recruitment (preemptive treatment of gurglers, after association was published)', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-21', 'studyFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2010-05-28', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital acquired pneumonia', 'timeFrame': '14 days (average)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hospital Acquired Pneumonia in Gurgling Patients']}, 'descriptionModule': {'briefSummary': 'Hospital inpatients who have gurgling sounds heard during speech or breathing have been observed to have a higher risk of hospital acquired pneumonia. Patients who gurgle and who consent to participation will be randomized to receive routine clinical management or management to include measures employed to reduce risks of aspiration, namely, 1. head of bed up (30 degrees or higher), 2. swallowing evaluation by speech therapist (and feeding predicated on formal evaluation), 3. prompting managing physicians to reduce sedating medications to minimal effective dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gurglers who consent to participate\n\nExclusion Criteria:\n\n* Non-gurglers\n* Patients presenting with pneumonia prior to identification with gurgling\n* Patients receiving comfort-care-only'}, 'identificationModule': {'nctId': 'NCT01134133', 'briefTitle': 'Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?', 'organization': {'class': 'OTHER', 'fullName': 'Bridgeport Hospital'}, 'officialTitle': 'Can Hospital Acquired Pneumonia be Prevented in Patients Who Gurgle?', 'orgStudyIdInfo': {'id': 'Gurgle'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anti-gurgling intervention', 'type': 'OTHER', 'description': '1\\. head of bed 30 degrees or higher, 2. swallowing evaluation-based feeding, 3. sedatives titrated to minimal effective dose.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bridgeport Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Constantine A. Manthous, MD', 'oldOrganization': 'Bridgeport Hospital'}}}}