Dislodgement Infiltration Phlebitis Prevention Eliminating Restarts (DIPPER)
Phase: NA
Conditions: IV Catheter-Related Infection or Complication
Sponsor: Lineus Medical

TP-013, Rev 03 PROTOCOL SYNOPSIS FOR CLINICALTRIALS.GOV 
HHC-IRB NUMBER: HHC-2020-0086 
IRB APPROVAL DATE: 10/13/2020 
 
TITLE 
Dislodgment Infiltration Phlebitis Prevention Eliminating 
Restarts (DIPPER) 
SPONSOR 
Lineus Medical 
FUNDING 
ORGANIZATION 
Lineus Medical 
STUDY START DATE 
June 2020 
RATIONALE 
Accidental IV catheter dislodgement and other 
mechanical complications (e.g., infiltration, phlebitis, 
infection, and occlusion) in hospitalized patients are very 
common. IV catheter mechanical complications increase 
costs and put patients at increased risk. SafeBreak 
Vascular is designed to separate into two pieces when a 
certain threshold of force is applied to an IV 
administration line. The purpose of this medical device 
investigation is to determine SafeBreak Vascular’s impact 
on clinical care (e.g., delay of therapy) and its’ impact on 
other IV catheter mechanical complications when 
compared to a control group of patients not using the 
device. 
STUDY DESIGN 
Prospective randomized clinical trial 
PRIMARY OBJECTIVE 
The primary objective of this study is to determine if the 
use of SafeBreak Vascular results in a delay in therapy 
that is non-inferior to the delay in therapy for the control 
group, and if so, if SafeBreak Vascular is superior. 
SECONDARY 
OBJECTIVES 
The secondary objective is to estimate the reduction of 
other peripheral IV (PIV) catheter mechanical 
complications including dislodgement, infection, phlebitis, 
infiltration, occlusion, as well as blood/fluid spillage and 
PIV restarts when compared to the control group. 
NUMBER OF SUBJECTS 
Up to 146 total (73 in each arm). This sample size allows 
for 10% of the subjects to abandon therapy before the 
normal completion of treatment. 
SUBJECT SELECTION 
CRITERIA 
Inclusion Criteria: 
• All patients admitted into the hospital to one of the 
following units: Neuro, Neuro/Step Down Epilepsy 
Pulmonary, Cardiothoraci, Surgery/Step Down; 
Medicine/Step Down, Vascular Thoracic 
 

 
 
Surgery/Step Down, B8- Surgery, B7E – 
Medicine/Step Down, B5-Vascular Thoracic 
Surgery 
• Patients of any gender may participate 
• Participants able to provide informed consent or 
have a legally authorized representative or Next of 
Kin 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 LAR 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 ED refuses to have new PIV 
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 
SUBJECT DEVICE / 
INTENDED USE 
SafeBreak is intended to stop fluid flow and prevent blood 
loss or fluid spillage in the event of excessive tension (4 
±1 lbs of force) occurs across a peripheral IV 

 
 
administration line in adults and adolescent populations 
eighteen (18) years of age or older. SafeBreak Vascular 
may be used only with electronic pumps for intermittent 
infusion or continuous infusion. 
CONTROL GROUP 
Participants with current standard of care for peripheral 
IVs. 
DURATION OF SUBJECT 
PARTICIPATION AND 
DURATION OF STUDY 
Study Participation Duration: Subjects in both groups 
will be followed for up to 7 days, or until the patient is 
discharged, or until IV access is discontinued. 
Duration of the Study: The study is expected to last at 
least two and up to three months. 
EFFICACY 
EVALUATIONS 
The primary and secondary objectives address the 
efficacy of the SafeBreak device. 
PRIMARY ENDPOINTS 
The primary endpoint is the time to re-start therapy 
following a mechanical complication with the catheter. 
SECONDARY 
ENDPOINTS 
Comparison of occurrence of mechanical complications 
(e.g., dislodgement, infection, infiltration, phlebitis, 
occlusion) as well as blood loss, fluid spillage and PIV 
restarts 
SAFETY EVALUATIONS 
The research team will evaluate all enrolled subjects at 
least twice daily for all adverse events and safety 
concerns and will document and communicate any 
concerns to the Investigator.