Evaluating the Usability of New Dialysis Bags

Evaluating the Usability of New Dialysis Bags for Continuous Renal Replacement Therapy: A Survey Among ICU Nurses

Objective: To compare the usability, efficiency, and ergonomics of new dialysis bags with current bags from the nursing perspective in ICU settings.

Study Type: Prospective, single-center observational study.

Methods: ICU nurses (126 total) will complete two surveys (pre- and post-implementation) evaluating both dialysis bags.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Replacement Therapies

Detailed Description

Rationale Continuous renal replacement therapy (CRRT) is commonly performed in adult ICUs, using large and heavy dialysate bags that require manual mixing, which can be cumbersome and time-consuming for ICU nurses. These bags are integral to the CRRT procedure but may introduce inefficiencies and safety concerns. With the introduction of newer dialysate bags designed for a lower environmental impact, it is important to evaluate how these new bags compare to the current products in terms of usability. The central question of this study is whether the new dialysis bags offer improved usability, efficiency, and ergonomic benefits for ICU nurses.

Objective(s) assess and compare the usability of the new dialysis bags with the currently used dialysis bags from the nursing perspective. The study will focus on evaluating ease of use, identifying problems encountered during use, and measuring efficiency during CRRT in an ICU setting.

Study type The study is a prospective, single-center research design. The study will be conducted in an ICU setting where nurses will be asked to evaluate the current and new dialysis bags at two time points: pre-implementation (evaluation of current bags) and post-implementation (evaluation of new bags).

Study population The study will include adult ICU nurses with at least 6 months of experience in administering CRRT. A total of 126 nurses (63 evaluating the current bags, 63 evaluating the new bags) will be invited to complete the usability questionnaire.

Methods The study will employ a two-time-point survey design. Nurses will first complete a survey evaluating the current dialysis bags. After approximately two months of using the new bags, a second survey will be conducted to assess the new bags. Both surveys will include Likert-scale questions and open-ended responses, focusing on the usability, safety, and efficiency of the dialysis bags. In the post-implementation survey, a head-to-head comparison will be included to directly compare the old and new bags across key usability domains such as ease of mixing, connection, leakage/contamination risks, changeover time, and ergonomic burden.

Burden and risks The burden on participants will be minimal, as the study involves completing two digital questionnaires (pre- and post-implementation). Participation will not interfere with clinical duties or patient care. There are no physical procedures or medical interventions involved, and the study poses no significant risks to participants.

Recruitment and consent Nurses will be recruited directly from the ICU and informed directly by a member of the research team. Participants will receive an information letter (PIF) describing the study's purpose, procedures, and voluntary nature. Informed consent will be obtained before participation. Participation is voluntary, and nurses may withdraw at any time without consequences for their employment or professional activities.

• Study Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

• Study Contact: Name: Michael C. van Herwerden, MD; Phone Number: 0031107040704; Email: m.vanherwerden@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

ICU nurses

Description

Inclusion Criteria:

• Nurse working in an adult intensive care unit (ICU)
• Competent in performing continuous renal replacement therapy (CRRT)

Exclusion Criteria:

• Nurses with less than 6 months of experience in administering CRRT, to ensure sufficient experience for a valid head-to-head comparison with the older dialysis bags.
• Nurses who are not directly involved in the handling or replacement of dialysis bags during CRRT procedures.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ICU nurses; ICU nurses with at least 6 months of experience in administering CRRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
usability	To assess the usability of the new dialysis bags compared to the current bags. This will be measured using Likert-scale responses from the usability survey, focusing on ease of use, safety, and efficiency during CRRT procedures. A head-to-head comparison will be performed	4 months

Collaborators and Investigators

• Sponsor: Erasmus Medical Center

Publications and helpful links

General Publications

• Hyzy M, Bond R, Mulvenna M, Bai L, Dix A, Leigh S, Hunt S. System Usability Scale Benchmarking for Digital Health Apps: Meta-analysis. JMIR Mhealth Uhealth. 2022 Aug 18;10(8):e37290. doi: 10.2196/37290.
• Colligan L, Potts HW, Finn CT, Sinkin RA. Cognitive workload changes for nurses transitioning from a legacy system with paper documentation to a commercial electronic health record. Int J Med Inform. 2015 Jul;84(7):469-76. doi: 10.1016/j.ijmedinf.2015.03.003. Epub 2015 Mar 22.

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: February 15, 2026
• First Submitted That Met QC Criteria: February 15, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Renal replacement therapy; acute kidney disease; Evalatuion study; ICU nurses
• Other Study ID Numbers: MEC-2025-0747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: On reasable request data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No