Early mobilization with or without cycloergometry in patients with septic shock in Intensive Care Unit: a randomized controlled trial.

PURPOSE: Acquired weakness in intensive care unit (ICU) contributes to increased mechanical ventilation (MV) and morbi-mortality. Cycloergometry could be added to standard physiotherapy (SP). The objective of the study was to determine the effect of early mobilization with cycloergometry and SP on ICU length of stay (LOS).

METHODS

This prospective, randomized, multicenter study included sedated-ventilated patients admitted to ICU for septic shock. ICU LOS was assessed in two phases. Phase I: from hemodynamic stability to first awakening, and phase II: from first awakening to ICU discharge. In each phase, patients were randomized to an intervention group: cycloergometry and SP (C+SP), or a control group (SP), generating four groups in total. In the intervention group, patients received a daily session of 20 min of cycloergometry in addition to SP.

RESULTS

From December 2016 to March 2020, 119 patients were included (instead of 234 planned). Mean SAPSII score at ICU admission was 59.5. Characteristics at baseline were similar. When phase I and phase II were analyzed separately, no statistical difference was observed between groups in time to first awakening or time to ICU discharge (phase I: C+SP 4 [IQR 2-7] days vs SP 4 [IQR 2-8] days, p = 0.6, and phase II: C+SP 9 [IQR 6-15] days vs SP 12 [IQR 6-28] days, p = 0.3).In post-hoc analysis when phase I and phase II were considered together, the median duration of MV was significantly longer in patients who received no cycloergometry (14 [IQR 8-60] days vs 9 [IQR 6-17] days, p = 0.04). Moreover, a trend was observed for a shorter time from hemodynamic stability to ICU discharge in patients who received cycloergometry in at least one phase: C+SP in phase I and/or phase II (13 [IQR 8-33] days) vs SP only (20 [IQR 11-66] days), p = 0.052.

CONCLUSION

Although the planned number of patients could not be included, a non-significant signal for decreased ICU LOS was observed in patients who received cycloergometry in at least one phase, in post-hoc analysis. Furthermore, cycloergometry was associated with a significantly lower duration of artificial ventilation.