Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814887
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2023-03-17
Brief Title:
Reduction of Mechanical IV Complication Using a New Medical Device
Sponsor:
Uppsala University Hospital
Organization:
Uppsala University Hospital
Study Overview
Official Title:
Reduction of Mechanical IV Complication Using a New Medical Device
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ReLink
Brief 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
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
Detailed Description:
It is estimated that around 15 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 76-16 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 andor aspiration is not possible and dislodgement the complete accidentalinadvertent 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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None