IV Dislodgement Comparative Effectiveness Study

IV Dislodgement Device Single Site Comparative Effectiveness Study

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.

Study Overview

• Status: Terminated
• Conditions: IVF
• Intervention / Treatment: Device: Dislodgement device

Detailed Description

Accidental dislodgement of peripheral venous assess devices occurs in up to 25% of all peripheral IV catheters. Accidental dislodgement is costly in terms of comfort, time, and resources. Dislodged IVs must usually be restarted and during the dislodgement period the patient is not receiving fluids and/or IV medications (delay or missed treatment). A few researchers reported the efficacy of various IV dressings related to their securement capabilities. Although dressings vary, the incidence of dislodgement was not associated with this method. Additionally, researchers have not explored the use of a break-away device that disconnects IV tubing from the IV catheter prior to dislodgement.

The purpose of this study is to determine if the addition of a break-away device results in fewer IV dislodgements than standard care alone. The aims of this study are 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; and to obtain feedback from nurses who used the break-away device regarding its strengths and limitations.

Four similar medical-surgical units at a quaternary care medical center will be used (H80 & 81 and H70 & 71). The floors (70s and 80s) will be randomly assigned to the study or control group by a coin flip at the beginning of the study. Two units will continue with customary IV dressing protocols and two units will use the break-away device in the IV tubing in addition to customary IV dressing.

Unit caregivers will be expected to record an IV dislodgement and restart date on the case report form at the time of the event. A research nurse will round on all patients on each unit daily.

The statistician has determined that to detect a 30% decrease in IV dislodgement, approximately 381 patients per group for 80% power would be required. As attrition is a potential threat for this study an additional 10% will be included in the final sample size calculations. Thus a total sample of 762 patients plus 10% (for attrition) will result in a sample of 838 patients with IVs for this study, to obtain the required 2286 patient days needed for analysis (based on an average of 3 patient days per subject).

For use in the regression model and to adjust (control) for differences in patient or environment characteristics that may impact dislodgement, the investigators will collect the following: patient characteristics (age, race, sex), environmental characteristics (time of day of dislodgment), and IV characteristics (IV catheter size, IV catheter site, right vs left).

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with IV fluids running through a peripheral line

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Usual care group; Usual IV securement
Dislodgement device group; Usual IV securement plus dislodgement device	Device: Dislodgement device; Breakaway device that prevents IV dislodgement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of IV dislodgements	Frequency of IV dislodgements	3-day hospital stay

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 22-1051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No