A Feasibility Study Evaluating the Use of SafeBreak Vascular in the Geriatric Trauma Population

NCT03505957 | Completed FDA Device

• 1 other identifier: v001 03.09.2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

SafeBreak Vascular is a medical device indicated for fluid flow control during the administration of IV fluids/medication to the patient's vascular system and to aid in the prevention of unintended disruption and dislodgment of IVs. SafeBreak Vascular may be used for any hospitalized patient with gravity tubing or IV pumps, for intermittent infusion or continuous infusion.The primary objective of this study is to determine if the delivery of IV medications and/or fluids with SafeBreak Vascular functions with the same reliability as current standard IV tubing.

Conditions

IV Dislodgement

Keywords

IV Dislodgement

Outcome Measures

Primary Outcomes (1)

• IV dislodgement rate

  Compare the study intervention's rate of IV dislodgement to the clinical literature's prospective observational studies that have a mean dislodgement of 17.5% and median of 9.2%.

  Up to 7 days

Secondary Outcomes (2)

• IV restarts

  Up to 7 days.

• Device related adverse events

  Up to 7 days

Study Arms (1)

SafeBreak Vascular Intervention

EXPERIMENTAL

Every study participant will have SafeBreak Vasculars installed in each of their IV lines.

Device: SafeBreak Vascular

Interventions

SafeBreak Vascular DEVICE

SafeBreak Vascular will be installed in all the IV lines of consenting participants for up to 7 days.

Also known as: SafeBreak

SafeBreak Vascular Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Geriatric trauma patients (\> or equal to age 55)
• Participants able to provide informed consent or have a legally authorized representative (LAR) provide consent
• The patients must have IV access (existing central venous catheter, peripherally inserted central catheter, or peripheral IV's) or need IV access
• The patients must be at least 55 years of age.

You may not qualify if:

• Unable to obtain informed consent or without an available LAR to provide surrogate informed consent
• Age less than or equal to 54
• Patient on comfort care only
• Predicted to have less than 24 hours survival
• Patient enrolled in an investigational drug or device study at the time of enrollment
• Investigator discretion that patient is not suitable for the study

Sponsors & Collaborators

• Lineus Medical: lead
• Washington University School of Medicine: collaborator
• Barnes-Jewish Hospital: collaborator

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940.

  PMID: 26557487 BACKGROUND

• Helm RE, Klausner JD, Klemperer JD, Flint LM, Huang E. Accepted but unacceptable: peripheral IV catheter failure. J Infus Nurs. 2015 May-Jun;38(3):189-203. doi: 10.1097/NAN.0000000000000100.

  PMID: 25871866 BACKGROUND

Study Officials

• Kelly Bochicchio, RN, MS

  Washington University School of Medicine

  STUDY DIRECTOR

• Stacey Reese, RN, MS

  Washington University of St. Louis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SafeBreak Vascular works with all IVs. The study participants will have SafeBreak Vasculars installed in all of their existing IV lines or new IV lines that are installed during their enrollment in the study.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 23, 2018
• Study Start: May 7, 2018
• Primary Completion: September 23, 2018
• Study Completion: September 23, 2018
• Last Updated: March 5, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)