Improvement of physical function in patients after admission to an intensive care unit (EMPRESS): protocol of a randomized controlled feasibility trial

BMJ open. 2022 Apr 15;12(4):e055285. doi: 10.1136/bmjopen-2021-055285.

ABSTRACT

INTRODUCTION: Physical rehabilitation provided early after admission to the intensive care unit (ICU) has the potential to improve short- and long-term outcomes. The use of supine cycling along with other rehabilitation techniques has potential as a method of introducing rehabilitation earlier in the patient journey. The objective of the study is to determine the feasibility of providing the designed protocol of a randomized clinical trial comparing a protocolized early rehabilitation program including cycling with usual care. This feasibility study will inform a larger multicenter study.

METHODS AND ANALYSIS: 90 acute care patients from two mixed medical-surgical intensive care units will be recruited. We will include patients ventilated within 72 hours of starting mechanical ventilation and who are expected to be ventilated for an additional 48 hours or more. Patients will receive usual care or usual care plus two 30-minute rehabilitation sessions 5 days/week. The feasibility results are (1) the recruitment of one to two patients per month and per site; (2) adherence to protocol with >75% of patients starting procedures within 72 hours of mechanical ventilation, with >70% of procedures performed; and (3) blinded outcome measures recorded at three time points in >80% of patients. The secondary outcomes are (1) strength and function, the graded ICU physical function test measured at discharge from the ICU; (2) length of hospital stay; and (3) mental health and physical ability at 3 months using the WHO Disability Rating Scale 2. Depression Scales core, Euroqol-5 Dimension-5 level and event score impact.

ETHICS AND DISSEMINATION: The study received ethics approval from the South Central Hampshire A Research Ethics Board (19/SC/0016). All amendments will be approved by this committee. An independent trial monitoring committee oversees the study. The results will be made available to critical care survivors, their caregivers, critical care societies and other researchers.

TEST REGISTRATION NUMBER: NCT03771014.

PMID:35428629 | DO I:10.1136/bmjopen-2021-055285