Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-25 @ 7:07 PM
Study NCT ID:
NCT02100735
Status:
WITHDRAWN
Last Update Posted:
2020-10-19
First Post:
2014-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Difficulty in with enrollment of patient', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2014-03-21', 'studyFirstSubmitQcDate': '2014-03-27', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days on mechanical ventilation', 'timeFrame': 'Participants will be assessed daily for the duration of their stay in the ICU, an expected average of 4-5 days'}], 'secondaryOutcomes': [{'measure': 'ICU Length of stay', 'timeFrame': 'Participants will be followed for the entire length of their ICU stay, expected average of 4-7 days'}, {'measure': '28 day mortality', 'timeFrame': 'Participants will be followed for 28 days from enrollment into the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sedatives', 'analgesics', 'protocol', 'mechanical ventilation', 'analgosedation'], 'conditions': ['Effect of Protocolized Sedation on Days of Mechanical Ventilation in the ICU']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how the investigators provide sedation (medicine that make you sleepy) in the investigators intensive care unit (ICU). This study will look at a new way of using sedation in the ICU to see what effect it has on patients and if it decreases the amount of time spent on mechanical ventilation (machine that breathes for you), and in the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age and older\n* Patients expected to require mechanical ventilation for greater than 48 hrs\n\nExclusion Criteria:\n\n* Need for continuous neuromuscular blockade\n* Severe chronic neurocognitive dysfunction\n* Tracheostomy at the time of study enrollment\n* Alcohol withdrawal risk or symptoms\n* Drug overdose\n* Chronic use of narcotics\n* Active seizures'}, 'identificationModule': {'nctId': 'NCT02100735', 'briefTitle': 'Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tampa General Hospital'}, 'officialTitle': 'Evaluation of an Analgosedation Protocol in Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': 'Pro00016830'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sedation protocol', 'description': 'Sedation protocol is a document that will be used to guide the adjustment of sedation in the ICU.', 'interventionNames': ['Other: Sedation protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of care', 'description': 'Current practices', 'interventionNames': ['Other: Sedation protocol']}], 'interventions': [{'name': 'Sedation protocol', 'type': 'OTHER', 'otherNames': ['The sedation protocol is a document that wil lbe used by healthcare providers to guide sedation used in the ICU'], 'description': 'Nursing driven sedation protocol', 'armGroupLabels': ['Sedation protocol', 'Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33569', 'city': 'Riverview', 'state': 'Florida', 'country': 'United States', 'facility': 'Beatrice Adams', 'geoPoint': {'lat': 27.86614, 'lon': -82.32648}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampa General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacotherapy Specialist', 'investigatorFullName': 'Beatrice Adams', 'investigatorAffiliation': 'Tampa General Hospital'}}}}