Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT04469218
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2020-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vance@lineusmed.com', 'phone': '844-546-3728', 'title': 'CEO', 'organization': 'Lineus Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Patients evaluated and adverse events documents at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first', 'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 33, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'SafeBreak Vascular Group', 'description': "Subjects in the SafeBreak Vascular group will have as near to identical treatment as possible to the control group with the exception that a SafeBreak Vascular device will be placed in the peripheral IV line.\n\nSafeBreak Vascular: SafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails.", 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 26, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phlebitis VIP =/>2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device Crack/Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'IV Site Bleeding/Fluid Leakage', 'notes': 'IV Repaced; IV site bleeding or fluid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mental Status Change/Unwitnessed Fall', 'notes': 'Altered mental status; Confusion, Hallucinations, unresponsive, unwitnessed fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Chemistry Abnormalities', 'notes': 'Decreasing hemoglobin\\&Hematocrit; high/low BP; low platelet count; low potassium; low sodium; O2 desaturation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Reactions', 'notes': 'Extremity itching; rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pains', 'notes': 'Abdominal pain; back pain; body aches, lower extremity pain; upper extremity pain; headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'notes': 'Chest pain, shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea/Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Temperature', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Catheter Placed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-op Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unwitnessed Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Delay in Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.'}, {'id': 'OG001', 'title': 'SafeBreak Vascular Group', 'description': "Subjects in the SafeBreak Vascular group will have as near to identical treatment as possible to the control group with the exception that a SafeBreak Vascular device will be placed in the peripheral IV line.\n\nSafeBreak Vascular: SafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails."}], 'classes': [{'categories': [{'measurements': [{'value': '11.73', 'spread': '36.56', 'groupId': 'OG000'}, {'value': '10.89', 'spread': '41.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first', 'description': 'A comparison in delays in therapy between the control group and the intervention group.', 'unitOfMeasure': 'min per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in Per Protocol population'}, {'type': 'SECONDARY', 'title': 'Estimate the Impact for Other Peripheral IV Complications.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.'}, {'id': 'OG001', 'title': 'SafeBreak Vascular Group', 'description': "Subjects in the SafeBreak Vascular group will have as near to identical treatment as possible to the control group with the exception that a SafeBreak Vascular device will be placed in the peripheral IV line.\n\nSafeBreak Vascular: SafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails."}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first', 'description': 'A comparison in IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart between the control group and the intervention group.', 'unitOfMeasure': 'mechanical complications', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients in Per Protocol population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.'}, {'id': 'FG001', 'title': 'SafeBreak Vascular Group', 'description': "Subjects in the SafeBreak Vascular group will have as near to identical treatment as possible to the control group with the exception that a SafeBreak Vascular device will be placed in the peripheral IV line.\n\nSafeBreak Vascular: SafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.'}, {'id': 'BG001', 'title': 'SafeBreak Vascular Group', 'description': "Subjects in the SafeBreak Vascular group will have as near to identical treatment as possible to the control group with the exception that a SafeBreak Vascular device will be placed in the peripheral IV line.\n\nSafeBreak Vascular: SafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '90'}, {'value': '59', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '89'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-13', 'size': 154735, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-19T12:16', 'hasProtocol': True}, {'date': '2020-10-13', 'size': 147001, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-12-19T12:16', 'hasProtocol': False}, {'date': '2020-07-27', 'size': 2732117, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-26T12:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The use of devices is randomly assigned to subjects in the study, but it is not possible to blind the patient, the care providers, the investigators or the outcomes assessor as to which group received the study device.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized clinical trial with a control group receiving the standard of care peripheral IV treatment and a second group that utilizes SafeBreak Vascular, a break-away connector, in the peripheral IV.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-19', 'studyFirstSubmitDate': '2020-07-08', 'resultsFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-19', 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delay in Therapy', 'timeFrame': 'Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first', 'description': 'A comparison in delays in therapy between the control group and the intervention group.'}], 'secondaryOutcomes': [{'measure': 'Estimate the Impact for Other Peripheral IV Complications.', 'timeFrame': 'Patients evaluated at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first', 'description': 'A comparison in IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart between the control group and the intervention group.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['IV Care', 'IV Complication'], 'conditions': ['IV Catheter-Related Infection or Complication']}, 'descriptionModule': {'briefSummary': "A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no SafeBreak Vascular) to determine SafeBreak Vascular's impact on IV clinical care and complications.", 'detailedDescription': "This randomized clinical trial's goal is to determine SafeBreak Vascular's impact, a break-away connector that separates when a harmful force is placed on a peripheral IV line, on IV clinical care and complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted into the participating hospital units\n* Patients of any gender may participate\n* Participants able to provide informed consent or have a legally authorized representative immediately available to provide informed consent\n* Patients must have peripheral IV catheter access or need and are planned to have peripheral IV catheter access placed that is anticipated to last a minimum of 24 hours.\n* Patients must be receiving intermittent or continuous infusion or have immediate plans to begin an intermittent or continuous infusion\n* The patients must be at least 18 years of age with no upper age limit\n\nExclusion Criteria:\n\n* Unable to obtain informed consent or without an available Legally Authorized Representative or Next of Kin to provide surrogate informed consent\n* Age less than or equal to 17\n* Patient on comfort care only\n* Predicted to have an IV infusion that lasts less than 24 hours\n* Patient admitted from the Emergency Department refuses to have new peripheral IV catheter placed by IV team\n* Patient has two or more peripheral IV catheters at the same time\n* Patient enrolled in a subject drug or device study at the time of enrollment\n* Investigator discretion that patient is not suitable for the study\n* Patient is COVID-19 positive\n* Patient is receiving an IV infusion with gravity tubing'}, 'identificationModule': {'nctId': 'NCT04469218', 'acronym': 'DIPPER', 'briefTitle': 'A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lineus Medical'}, 'officialTitle': 'Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)', 'orgStudyIdInfo': {'id': 'P002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.'}, {'type': 'EXPERIMENTAL', 'label': 'SafeBreak Vascular Group', 'description': 'Subjects in the SafeBreak Vascular group will have as near to identical treatment as possible to the control group with the exception that a SafeBreak Vascular device will be placed in the peripheral IV line.', 'interventionNames': ['Device: SafeBreak Vascular']}], 'interventions': [{'name': 'SafeBreak Vascular', 'type': 'DEVICE', 'otherNames': ['Patient safety disconnect'], 'description': "SafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails.", 'armGroupLabels': ['SafeBreak Vascular Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Lee Steere', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hartford Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lineus Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hartford HealthCare', 'class': 'OTHER'}, {'name': 'Hartford Hospital', 'class': 'OTHER'}, {'name': 'Technomics Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}