IV Dislodgement Comparative Effectiveness Study

NCT ID: NCT05602285

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-04
• Study Completion Date: 2024-12-31

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.

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).

Conditions

IVF

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Usual care group

Usual IV securement

No interventions assigned to this group

Dislodgement device group

Usual IV securement plus dislodgement device

Dislodgement device

Intervention Type: DEVICE

Breakaway device that prevents IV dislodgement

Interventions

Dislodgement device

Breakaway device that prevents IV dislodgement

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Sandra Siedlecki

Senior Nurse Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

22-1051

Identifier Type: -

Identifier Source: org_study_id