Adverse events during and after early mobilisation: A post hoc analysis of the TEAM trial.

Abstract

Background: The Treatment of Mechanically Ventilated Adults with Early Activity and Mobilisation (TEAM) trial reported a higher occurrence of adverse events with greater mobilisation. However, their timing and nature remained unexplored. We conducted an in-depth exploration of such events.

Objective: The purpose of this paper is to thoroughly examine the timing and characteristics of adverse events reported within the TEAM trial.

Methods: Adverse event data were collected daily in real time. Categorical data were compared using the Fisher's exact test. The relationship between adverse events and patient survival was analysed using a Cox-regression frailty model.

Results: Overall, 37 out of 371 patients (10.0%) in the early mobilisation group and 16 out of 370 patients (4.3%) in the usual care group experienced adverse events, with 71 events in the early mobilisation group compared to 24 events in the usual care group. The most common adverse events were altered blood pressure in 21 out of 53 patients (39.6%), arrhythmia in 17 out of 53 patients (32.1%), and oxygen desaturation in nine of 53 patients (17.0%). Patients with an adverse event were more likely to have congestive heart failure (absolute percentage difference: 16.1, 95% confidence interval [CI]: 6.1 to 26.1), peripheral vascular disease (absolute percentage difference: 6.4, 95% CI: 1.3 to 11.5), heart attack (absolute percentage difference: 13.5, 95% CI: 5.9 to 21.1), or stroke (absolute percentage difference: 9.3, 95% CI: 3.5 to 15.1). Adverse events occurred at a median of 4 days with early mobilisation and 7 days with usual care. There was no significant difference in survival for patients who experienced an adverse event compared to those without an adverse event.

Conclusion: Adverse events were more common in patients randomised to early active mobilisation, were cardiovascular and respiratory in nature, tended to occur earlier with active mobilisation, and cardiovascular comorbidities were more common in such patients. This information can help guide future studies in this field.

Trial registration: TEAM ClinicalTrials.gov number, NCT03133377, registered 28 April 2017.