IV Catheter-Related Infection or Complication
Conditions
Keywords
IV Care, IV Complication
Brief summary
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.
Detailed description
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.
Interventions
DEVICESafeBreak 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.
Sponsors
Hartford HealthCare
Hartford Hospital
Technomics Research
Lineus Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients admitted into the participating hospital units * Patients of any gender may participate * Participants able to provide informed consent or have a legally authorized representative immediately available to provide informed consent * 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. * Patients must be receiving intermittent or continuous infusion or have immediate plans to begin an intermittent or continuous infusion * The patients must be at least 18 years of age with no upper age limit
Exclusion criteria
* Unable to obtain informed consent or without an available Legally Authorized Representative or Next of Kin to provide surrogate informed consent * Age less than or equal to 17 * Patient on comfort care only * Predicted to have an IV infusion that lasts less than 24 hours * Patient admitted from the Emergency Department refuses to have new peripheral IV catheter placed by IV team * Patient has two or more peripheral IV catheters at the same time * Patient enrolled in a subject drug or device study at the time of enrollment * Investigator discretion that patient is not suitable for the study * Patient is COVID-19 positive * Patient is receiving an IV infusion with gravity tubing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delay in Therapy | 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 | A comparison in delays in therapy between the control group and the intervention group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the Impact for Other Peripheral IV 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 | A comparison in IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart between the control group and the intervention group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital. | 69 |
| 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. | 70 |
| Total | 139 |
Baseline characteristics
| Characteristic | SafeBreak Vascular Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 59 Years | 59 Years | 59 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 28 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 111 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 59 Participants | 120 Participants | 61 Participants |
| Sex: Female, Male Female | 27 Participants | 59 Participants | 32 Participants |
| Sex: Female, Male Male | 43 Participants | 80 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 70 |
| other Total, other adverse events | 33 / 69 | 26 / 70 |
| serious Total, serious adverse events | 2 / 69 | 2 / 70 |
Outcome results
Primary
Delay in Therapy
A comparison in delays in therapy between the control group and the intervention group.
Time frame: 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
Population: All patients in Per Protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Delay in Therapy | 11.73 min per 24 hours | Standard Deviation 36.56 |
| SafeBreak Vascular Group | Delay in Therapy | 10.89 min per 24 hours | Standard Deviation 41.45 |
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.
Time frame: 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
Population: All patients in Per Protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control Group | Estimate the Impact for Other Peripheral IV Complications. | 25 mechanical complications |
| SafeBreak Vascular Group | Estimate the Impact for Other Peripheral IV Complications. | 15 mechanical complications |