Reduction of Mechanical IV Complication Using a New Medical Device

NCT05814887 | Completed

• 1 other identifier: ReLink
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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,

Conditions

Catheter Complications

Outcome Measures

Primary Outcomes (1)

• The rate of mechanical complications of an IV therapy session using a new medical device (ReLink) compared to using current 'state of the art'.

  Mechanical complications is defined as phlebitis, subcutaneous infiltration, occlusion or dislodgement

  Up to one week from randomization

Secondary Outcomes (3)

• Frequency and severity of any adverse events

  Up to one week from randomization

• Healthcare workers opinion of the new medical device

  Within one week of removal of the device

• The economic cost of these disruptions to the hospital or healthcare facility in terms of man-hours, and resources

  Through study completion, an average of 1 year

Study Arms (2)

ReLink

EXPERIMENTAL

Medical device to be tested

Device: ReLink

Control

NO INTERVENTION

Control, no medical device

Interventions

ReLink DEVICE

Medical device

ReLink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has or will get a PIVC expected to be used for continuous or intermittent IV infusion therapy. Continuous IV infusion is defined as an infusion ≥ 2h and intermittent as an infusion lasting 15min to \< 2h.
• ≥18 years of age
• Speaks and understands Swedish

You may not qualify if:

• The PIVC is expected to be used for sampling only
• Pregnancy
• Unable to obtain informed consent or without an available Next-of-kin to provide surrogate informed consent
• Patients under palliative care
• Bolus IV infusion, defined as an infusion time of \<15 min

Sponsors & Collaborators

• Uppsala University Hospital: lead

Study Sites (1)

Christopher Blacker

Uppsala, Uppsala County, 75185, Sweden

Location

Related Publications (1)

• Blacker C, Modiri AR, Ljungman G, Frykholm P. The effects of a new device on mechanical complications of short peripheral intravenous catheters: A randomized controlled trial. J Vasc Access. 2025 Nov 11:11297298251389658. doi: 10.1177/11297298251389658. Online ahead of print.

  PMID: 41216825 DERIVED

Study Officials

• Peter Frykholm, M.D., Ph.D.

  Dept of Anesthesia and Intensive Care, Uppsala University Hospital, 751 85 Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: April 18, 2023
• Study Start: May 4, 2023
• Primary Completion: November 12, 2023
• Study Completion: March 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)