Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05814887 |
| Other study ID # |
ReLink |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 4, 2023 |
| Est. completion date |
March 1, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Uppsala University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Peripheral intravenous catheters are necessary for in-hospital medical treatment. Malfunction
due to occlusion or dislodgement is common, and increases the burden on health care.
The aim of this study is to determine if the use of a new medical device has an impact on
mechanical complications rate when peripheral intravenous (IV) catheter is used. The study
will also investigate the safety, opinions of healthcare personnel and health economic
effects of this new device,
Description:
It is estimated that around 1.5 billion peripheral intravenous catheters (PIVC) are sold
every year globally, and placing them is one of the most common invasive procedures in
hospitalised patients, with up to 90% receiving one, yet there is a failure rate of up to
69%. Some of the most common causes of failure are considered to be phlebitis, subcutaneous
infiltration, occlusion and dislodgement. These failure rates vary widely, where published
data suggests rates of 8-44% for phlebitis, 5-21% for infiltration, 7.6-16% for occlusion and
5-10% for dislodgement. Phlebitis, commonly defined as an inflammatory process in the wall of
a vein, resulting in a blood clot formation; while infiltration is defined as the inadvertent
leakage of a solution into the surrounding tissue; occlusion is defined as PIVC failure due
to blockage where flushing and/or aspiration is not possible, and dislodgement the complete
accidental/inadvertent removal of the PIVC before intended. Previous studies have suggested
that mechanical irritation could be an important factor resulting in PIVC failure. In the
case of phlebitis, mechanical movements against the endothelial wall could initiate a cascade
of prothrombotic events resulting in the formation of a blood clot, something that has been
demonstrated in a simulated environment.
Therefore, there is a need to investigate potential new methods for prevention of these
mechanical complications, and one way could be in the reduction of mechanical forces acting
on the vessels. The aim of this study is to investigate the safety and effectiveness of a new
medical device in reducing the number of mechanical complications during IV therapy.
The investigators have divided the research questions into a primary endpoint and secondary
endpoints.
1. Primary endpoint:
The rate of mechanical complications of an IV therapy session using a new medical device
(ReLink) compared to using current 'state of the art'.
2. Secondary endpoint:
- Frequency and severity of any adverse events
- Healthcare workers opinion of the new medical device
- The economic cost of these disruptions to the hospital or healthcare facility in
terms of man-hours, and resources
The study is a randomized controlled trial to be run at Uppsala University Hospital. Patients
will be randomly assigned to either the experimental group receiving IV infusion treatment
using the new medical device ReLink, or the control group receiving IV infusion treatment
without the device. Once the full intended IV infusion treatment has been completed, the same
patient may be re-randomized and re-included in the trial. In case there is a mechanical
complication resulting in the exchange of peripheral catheter, the patient will be
re-randomized to either the control or intervention group. The risk of introducing a bias by
re-randomizing the patients has been analysed and is considered to be minor. Firstly, in case
of a re-randomization, this will take place after the follow-up of a peripheral catheter is
completed. Secondly, re-randomization has been chosen instead of a cross-over design (where a
patient's second peripheral catheter would automatically be selected to the other group) to
avoid a spill-over effect from the patient themselves being biased against or in favour of
using the device.
