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| Name | Class |
|---|---|
| Hartford HealthCare | OTHER |
| Hartford Hospital | OTHER |
| Technomics Research | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital. | |
| SafeBreak Vascular Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SafeBreak Vascular | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Delay in Therapy | A comparison in delays in therapy between the control group and the intervention group. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate the Impact for Other Peripheral IV Complications. | A comparison in IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart between the control group and the intervention group. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee Steere | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital. |
| FG001 | SafeBreak Vascular Group | 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. SafeBreak 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital. |
| BG001 | SafeBreak Vascular Group | 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. SafeBreak 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Delay in Therapy | A comparison in delays in therapy between the control group and the intervention group. | All patients in Per Protocol population | Posted | Mean | Standard Deviation | min per 24 hours | 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 |
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dislodgement | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CEO | Lineus Medical | 844-546-3728 | vance@lineusmed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2020 | Dec 19, 2023 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2020 | Dec 19, 2023 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2020 | Apr 26, 2022 | ICF_001.pdf |
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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.
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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.
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Estimate the Impact for Other Peripheral IV Complications. | A comparison in IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart between the control group and the intervention group. | All patients in Per Protocol population | Posted | Number | mechanical complications | 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 |
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| 0 |
| 69 |
| 2 |
| 69 |
| 33 |
| 69 |
| EG001 | SafeBreak Vascular Group | 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. SafeBreak 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. | 0 | 70 | 2 | 70 | 26 | 70 |
| Unwitnessed Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Infiltration | Surgical and medical procedures | Systematic Assessment |
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| Phlebitis VIP =/>2 | Surgical and medical procedures | Systematic Assessment |
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| Occlusion | Surgical and medical procedures | Systematic Assessment |
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| Device Crack/Leak | Product Issues | Systematic Assessment |
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| IV Site Bleeding/Fluid Leakage | Surgical and medical procedures | Systematic Assessment | IV Repaced; IV site bleeding or fluid |
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| Mental Status Change/Unwitnessed Fall | Psychiatric disorders | Systematic Assessment | Altered mental status; Confusion, Hallucinations, unresponsive, unwitnessed fall |
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| Blood Chemistry Abnormalities | Blood and lymphatic system disorders | Systematic Assessment | Decreasing hemoglobin&Hematocrit; high/low BP; low platelet count; low potassium; low sodium; O2 desaturation |
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| Skin Reactions | Skin and subcutaneous tissue disorders | Systematic Assessment | Extremity itching; rash |
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| Pains | General disorders | Systematic Assessment | Abdominal pain; back pain; body aches, lower extremity pain; upper extremity pain; headache |
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| Cardiovascular | Cardiac disorders | Systematic Assessment | Chest pain, shortness of breath |
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| Nausea/Diarrhea | General disorders | Systematic Assessment |
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| Elevated Temperature | General disorders | Systematic Assessment |
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| Urinary Catheter Placed | Renal and urinary disorders | Systematic Assessment |
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| Post-op Complication | General disorders | Systematic Assessment |
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