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Not Yet RecruitingNCT07426575

Evaluating the Usability of New Dialysis Bags

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
126 (estimated)
Sponsor
Erasmus Medical Center · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Timeline

Start date
2026-02-15
Primary completion
2026-06-15
Completion
2027-06-15
First posted
2026-02-23
Last updated
2026-02-23

Source: ClinicalTrials.gov record NCT07426575. Inclusion in this directory is not an endorsement.