NCT05602285

Brief Summary

The goal of this comparative effectiveness study is to compare IV dislodgement frequency in medical-surgical patients with continuous IV fluids infusing. The main question it aims to answer are: 1\. To determine if the addition of the break-away IV device within IV tubing and customary IV dressing reduces dislodgment when compared to customary IV dressing alone.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 4, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

October 27, 2022

Last Update Submit

May 13, 2025

Conditions

IVF

Outcome Measures

Primary Outcomes (1)

  • Frequency of IV dislodgements

    Frequency of IV dislodgements

    3-day hospital stay

Study Arms (2)

Usual care group

Usual IV securement

Dislodgement device group

Usual IV securement plus dislodgement device

Device: Dislodgement device

Interventions

Dislodgement deviceDEVICE

Breakaway device that prevents IV dislodgement

Dislodgement device group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with IV fluids running through a peripheral line

You may qualify if:

  • Patient with IV fluids running through peripheral line Adult medical/surgical patients

You may not qualify if:

  • Patients \<18 years old Adult patients with central lines (PICC, triple lumen, med-port) No continuous IVF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Nurse Scientist

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 2, 2022

Study Start

January 4, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)