Clinical trial NCT04469218: A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
Official title: Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IV Catheter-Related Infection or Complication
Keywords: IV Care
IV Complication
Lead sponsor: Lineus Medical
Sponsor class: INDUSTRY
Collaborators: name: Hartford HealthCare
name: Hartford Hospital
name: Technomics Research
First posted: 2020-07-13
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Lee Steere
role: PRINCIPAL_INVESTIGATOR
References: