Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03725293 |
| Other study ID # |
2018-379 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 14, 2019 |
| Est. completion date |
November 26, 2020 |
Study information
| Verified date |
January 2022 |
| Source |
William Beaumont Hospitals |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Peripherally inserted central catheters (PICCs) are central catheters that are placed via
peripheral vein under ultrasound guidance and may be used for patients with difficult venous
access for long-term central or peripheral infusion therapies as well as central venous
pressure monitoring in a critical care setting. Although PICCs provide a great option for
some patients, these catheters have known complications including catheter-related
bloodstream infection, catheter-related venous thrombosis or clotting, malfunction, and high
cost. Midline catheters represent a potentially attractive alternative to PICCs for
peripheral infusions. As midlines have increased in popularity and new midlines have been
introduced into the market, it is necessary to better understand complication profiles of
various midline catheters, as it is likely that all catheters are not created equal.
Specifically, the incidence of symptomatic catheter-related thrombosis is of interest. Some
midline catheters are coated to provide protection against catheter-related venous thrombosis
and/or catheter-related bloodstream infection. The theoretical benefit(s) of these catheters
need further validation in human subjects.
Description:
Study Design
The investigators propose a prospective single-site, parallel, two-arm, randomized
investigation to assess catheter-related symptomatic upper extremity venous thrombosis
(CR-UEVT), catheter-related bloodstream infection, and functionality of two single lumen
midline catheters: AngioDynamics BioFlo 4 F and Teleflex Arrowg+ard Blue Advance 4.5 F.
Research staff of Beaumont Health Institute will allocate two midline catheters to eligible
participants according to a pre-generated randomized list at a 1:1 ratio in block
randomization to AngioDynamics BioFlo or Tele-flex Arrowg+ard Blue Advanced midline
catheters. Participant enrollment will take place from November 2018 until recruitment of 250
participants, 125 in each group, is complete. Demographic and health-related information will
be obtained from electronic medical records during enrolled period at William Beaumont
Hospital.
Practitioner Participation/Training
Advanced Practice Providers within the bedside PICC/Midline service at the Royal Oak campus
are eligible to place catheters for this study. All investigators are credentialed in placing
PICCs and midlines by institutional policy and have greater than one year of experience in
these procedures.
Initial Assessment
Post-cannulation and post securement, functionality is confirmed with blood sampling (10 cc)
and flush without resistance.
The research team also will document practitioner details, the vascular access device (VAD)
used, the time of VAD placement, number of attempts, need for a rescue inserter, the vein
that was cannulated, depth and diameter of the vein, and the indication for VAD placement. An
attempt is defined as each time the needle punctures the skin. Data will be collected from
the electronic medical record and includes: age, gender, body mass index (BMI), vital signs,
relevant past medical history. Indication for catheter placement will also be recorded.
Follow-up Assessment
Investigators will perform a follow-up assessment on all catheters within 24 hours of
insertion and then daily for the life of the VAD. At each follow-up interval, the researcher
will document the time of evaluation and assessment of functionality as well as review the
patient chart for signs and symptoms of catheter-related bloodstream infection. If the
catheter was identified to have failed during follow-up assessment the date and time of
failure and the reason for failure will be documented. For all failed catheters, re-insertion
attempt data will be tracked through the medical record.
Superficial venous thrombosis (SVT) and deep venous thrombosis (DVT) rates will be calculated
based on upper extremity proven diagnosis of SVT and/or DVT in symptomatic cases. Radiology
interpretations will be reviewed for findings consistent with CR-UEVT.
Infection rate will be tracked using confirmed catheter-related blood stream infection data
from the surveillance team within the epidemiology department. The team utilizes the CDC
definition of laboratory-confirmed blood-stream infection (LCBSI).
The medication administration record will be queried for all medications given through each
catheter.
