N/A
N=148
A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
IV Catheter-Related Infection or Complication
Bottom Line
View on ClinicalTrials.gov: NCT04469218 ↗Enrolled (actual)
148
Serious AEs
2.9%
Results posted
Jan 2024
Primary outcome: Primary: Delay in Therapy — 11.73; 10.89 min per 24 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SafeBreak Vascular (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lineus Medical
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delay in Therapy |
11.73; 10.89 | — |
| SECONDARY Estimate the Impact for Other Peripheral IV Complications. |
25; 15 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04469218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.