Early mobilisation using a mobile patient lift in the intensive care unit: protocol for a randomised controlled trial

Abstract

IntroductionIt is important to prevent the deterioration of activities of daily living to improve the long-term prognoses of patients in the intensive care unit (ICU). The patients’ conditions, along with the lack of human and technical resources, often become barriers to achieving early mobilisation after the introduction of mechanical ventilation. We plan to verify the usefulness of a mobile patient lift for early mobilisation.Methods and analysisWe will conduct a single-centre, open-label, randomised controlled trial. The inclusion criteria are as follows: age ≥18 years, independent walking before admission and expected mechanical ventilation for at least 48 hours. The participants will be randomly divided into groups with (intervention group) or without (control group) a mobile lift protocol. A mobile lift will be used in the intervention group. The primary endpoint will be the number of days required to achieve an ICU mobility scale of ≥4 (standing position). The results of the two groups will be analysed using the Student’s t-test.Ethics and disseminationThis study will be conducted in accordance with the Declaration of Helsinki and with the approval of the Toho University Omori Medical Center Ethics Committee (approval number M20259). The results of this study will be presented internationally at academic conferences and published in the literature.Trial registration numberUMIN000044965.

The Future for Early Mobilization Clinical Trials? Lessons From the Business World With Hype Curves and Shrinking the Change Strategies*

“…Most current early mobilization trials struggle to describe intervention and control group protocols in sufficient detail to allow for replication. The trial by Suzuki et al (8) studied a specific intervention's (a patient lift system) impact on the ability to deliver early mobilization in the ICU. The authors' incremental approach to investigating early mobilization implementation may inform physical therapists and nurses working in similar ICUs on how to best maximize patient interventions and to coordinate care between clinicians.…”

“…The authors' incremental approach to investigating early mobilization implementation may inform physical therapists and nurses working in similar ICUs on how to best maximize patient interventions and to coordinate care between clinicians. Another benefit of the study by Suzuki et al (8) is the team was able to expand their existing early mobilization protocol to address the needs of other patients who may not have been able to previously participate in early mobilization.…”

“…To fully address patient needs beyond the ICU, future research can determine if the functional improvements reported in studies like the trial by Suzuki et al (8) lead to greater function at hospital discharge and during longer term out of hospital function. Similarly, other studies will need to examine the effect of patient lift systems on reducing potential complications associated with immobility such as wounds, weakness, and decreased cardiopulmonary capacity.…”

“…The goal of a clinical trial is not only to determine the efficacy of an intervention but also to have the proven and beneficial interventions disseminated and easily implemented by healthcare providers around the world. As the study by Suzuki et al (8) demonstrates, one way to move the early mobilization field forward is to conduct clinical trials that focus on specific and more reproducible interventions. Their targeted and relatively straightforward study design uses an established management style of “shrinking the change.” As highlighted in the book “Switch” by Heath and Heath (9), people, organizations, and society in general are averse to change, and the process to change any type of practice or behavior can be very difficult.…”

“…The study by Suzuki et al (8) is a definite small win for the critical care community. Their results pave the wave for future trials that may collectively clarify the early mobilization literature and help clinicians know how to enhance the physical function of their ICU survivors.…”