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Evaluation of a closed loop-blood sampling system in intensive care: A pilot randomised controlled trial. The ENCLOSE trial

School of Nursing and Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, Australia; Centre for Nursing and Midwifery Research and Intensive Care Services, Royal Brisbane and Women's Hospital, Brisbane, Australia; Alliance for Vascular Access Teaching and Research (AVATAR), School of Nursing and Midwifery, Griffith University, Brisbane, Australia. Electronic address: s2.keogh@qut.edu.au. Centre for Nursing and Midwifery Research and Intensive Care Services, Royal Brisbane and Women's Hospital, Brisbane, Australia; UQ Centre for Clinical Research, Faculty of Medicine, University of Queensland, Brisbane, Australia. School of Nursing and Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, Australia; Centre for Nursing and Midwifery Research and Intensive Care Services, Royal Brisbane and Women's Hospital, Brisbane, Australia. Centre for Nursing and Midwifery Research and Intensive Care Services, Royal Brisbane and Women's Hospital, Brisbane, Australia. School of Nursing and Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, Australia. UQ Centre for Clinical Research, Faculty of Medicine, University of Queensland, Brisbane, Australia. Centre for Immunology and Infection Control, Queensland University of Technology, Brisbane, Australia.

Intensive & critical care nursing. 2022;:103364
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PICO Summary

Population

Adult patients in intensive care enrolled in the ENCLOSE trial (n= 80).

Intervention

Closed-loop blood system sampling and conservation bundle aligned with national guidelines (n= 41).

Comparison

Standard care: open-loop blood sample system (n= 39).

Outcome

Some of the feasibility outcomes of this pilot trial were met, including some aspects of recruitment (i.e., patient consent), retention and data integrity. The proportion of patients eligible was 29 % and missed eligible was 65 %. Otherwise, feasibility criteria were met with proportion of eligible patients agreeing to enrolment 99 %, 100 % of patients receiving allocated treatment; only 1 % of data missing. Analysis demonstrated a significant reduction in mean daily blood sample losses (open 32.7 (SD 1.58) mL vs. closed 15.5 (SD 5.79) mL, t= -8.454, df= 78).
Abstract
OBJECTIVE To test the feasibility of conducting a randomised controlled trial to evaluate the impact of a closed-loop blood sampling system and blood conservation bundle. METHODS Single site, parallel group, pilot randomised control trial comparing open system sampling to closed system sampling and conservation bundle aligned with national guidelines. Randomisation sequence was generated by an independent statistician and allocation concealment maintained via sealed opaque envelopes. The study setting was the general intensive care unit of a major metropolitan public hospital in Queensland, Australia. Participants were ≥ 18 years who had an arterial catheter inserted in intensive care. Main outcome measures included trial feasibility, blood sample loss, haematocrit (HCT) change, and packed red blood cell transfusion use. RESULTS Eighty patients were randomised (n = 39 open group, n = 41 closed group). Characteristics in each group were equal at baseline with overall median age 60 years (IQR 48.6-70.4), 58 % male, and median APACHE II score 16 (IQR 11-22). The proportion of patients eligible was 29 % and missed eligible was 65 %. Otherwise, feasibility criteria were met with proportion of eligible patients agreeing to enrolment 99 %, 100 % of patients receiving allocated treatment; only 1 % of data missing. Analysis demonstrated a significant reduction in mean daily blood sample losses (open 32.7 (SD 1.58) mL vs closed 15.5 (SD 5.79) mL, t = -8.454, df = 78, p < 0.001). CONCLUSIONS A large, multi-site trial is feasible with enhanced eligibility criteria, increased recruitment support. The intervention reduced daily blood sample volumes and transfusion use. Further trials are required to provide both effectiveness and implementation outcomes.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine