Trial Outcomes & Findings for A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications (NCT NCT04469218)
NCT ID: NCT04469218
Last Updated: 2024-01-16
Results Overview
A comparison in delays in therapy between the control group and the intervention group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome 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
Results posted on
2024-01-16
Participant Flow
Participant milestones
| Measure |
Control Group
Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
|
Overall Study
COMPLETED
|
69
|
70
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
Baseline characteristics by cohort
| Measure |
Control Group
n=69 Participants
Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.
|
SafeBreak Vascular Group
n=70 Participants
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.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 Years
n=5 Participants
|
59 Years
n=7 Participants
|
59 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
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 firstPopulation: All patients in Per Protocol population
A comparison in delays in therapy between the control group and the intervention group.
Outcome measures
| Measure |
Control Group
n=69 Participants
Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.
|
SafeBreak Vascular Group
n=70 Participants
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.
|
|---|---|---|
|
Delay in Therapy
|
11.73 min per 24 hours
Standard Deviation 36.56
|
10.89 min per 24 hours
Standard Deviation 41.45
|
SECONDARY outcome
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 firstPopulation: All patients in Per Protocol population
A comparison in IV complications (dislodgement, infiltration, and phlebitis VIP =2 or greater) requiring IV restart between the control group and the intervention group.
Outcome measures
| Measure |
Control Group
n=69 Participants
Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.
|
SafeBreak Vascular Group
n=70 Participants
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.
|
|---|---|---|
|
Estimate the Impact for Other Peripheral IV Complications.
|
25 mechanical complications
|
15 mechanical complications
|
Adverse Events
Control Group
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
SafeBreak Vascular Group
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=69 participants at risk
Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.
|
SafeBreak Vascular Group
n=70 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
2.9%
2/69 • Number of events 2 • 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
|
1.4%
1/70 • Number of events 1 • 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
|
|
Injury, poisoning and procedural complications
Unwitnessed Fall
|
0.00%
0/69 • 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
|
1.4%
1/70 • Number of events 1 • 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
|
Other adverse events
| Measure |
Control Group
n=69 participants at risk
Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital.
|
SafeBreak Vascular Group
n=70 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
Dislodgement
|
4.3%
3/69 • Number of events 4 • 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
|
2.9%
2/70 • Number of events 2 • 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
|
|
Surgical and medical procedures
Infiltration
|
10.1%
7/69 • Number of events 10 • 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
|
11.4%
8/70 • Number of events 8 • 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
|
|
Surgical and medical procedures
Phlebitis VIP =/>2
|
14.5%
10/69 • Number of events 10 • 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
|
1.4%
1/70 • Number of events 1 • 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
|
|
Surgical and medical procedures
Occlusion
|
1.4%
1/69 • Number of events 1 • 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
|
5.7%
4/70 • Number of events 4 • 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
|
|
Product Issues
Device Crack/Leak
|
0.00%
0/69 • 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
|
2.9%
2/70 • Number of events 2 • 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
|
|
Surgical and medical procedures
IV Site Bleeding/Fluid Leakage
|
1.4%
1/69 • Number of events 1 • 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
|
2.9%
2/70 • Number of events 2 • 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
|
|
Psychiatric disorders
Mental Status Change/Unwitnessed Fall
|
4.3%
3/69 • Number of events 5 • 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
|
1.4%
1/70 • Number of events 1 • 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
|
|
Blood and lymphatic system disorders
Blood Chemistry Abnormalities
|
10.1%
7/69 • Number of events 8 • 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
|
2.9%
2/70 • Number of events 2 • 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
|
|
Skin and subcutaneous tissue disorders
Skin Reactions
|
1.4%
1/69 • Number of events 1 • 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
|
1.4%
1/70 • Number of events 1 • 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
|
|
General disorders
Pains
|
18.8%
13/69 • Number of events 13 • 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
|
5.7%
4/70 • Number of events 6 • 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
|
|
Cardiac disorders
Cardiovascular
|
2.9%
2/69 • Number of events 2 • 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
|
5.7%
4/70 • Number of events 4 • 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
|
|
General disorders
Nausea/Diarrhea
|
5.8%
4/69 • Number of events 7 • 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
|
2.9%
2/70 • Number of events 3 • 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
|
|
General disorders
Elevated Temperature
|
7.2%
5/69 • Number of events 6 • 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
|
0.00%
0/70 • 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
|
|
Renal and urinary disorders
Urinary Catheter Placed
|
1.4%
1/69 • Number of events 1 • 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
|
0.00%
0/70 • 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
|
|
General disorders
Post-op Complication
|
1.4%
1/69 • Number of events 1 • 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
|
0.00%
0/70 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place