ROBotic-assisted Early Mobilization in ventilated surgical critically ill patients (ROBEM-I)—A randomized, controlled, outcome-assessor-blinded pilot study

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BACKGROUND: A shortage of human resources is a key barrier to the early mobilization of mechanically ventilated ICU patients. Recent advancements in robotic mobilization systems offer promising solutions to this challenge. OBJECTIVE(S): This study assessed the operability of an AI-assisted robotic mobilization system by a single healthcare provider, along with its safety, feasibility, and potential benefits for mechanically ventilated surgical ICU patients. DESIGN: Randomized controlled pilot study. SETTING: Five surgical ICUs at Charité - Universitätsmedizin Berlin, Germany, November 2020 to September 2022. PATIENTS: Twenty critically ill patients requiring >24 h of mechanical ventilation. INTERVENTION(S): Twice-daily robotic-assisted mobilization sessions ≥ 20 min over five days, compared to the control group receiving standard care. MAIN OUTCOME MEASURES: Number of mobilization sessions conducted by a single person. RESULTS: In the robotic-assisted group, no mobility sessions were conducted by a single person (0%) vs. 26 (96%) in the control group (p < 0.001). Significant secondary outcomes included a mobilization duration of 41 min/day [IQR 36-47] in the intervention group vs. 19 min/day [IQR 13-21] in the control group (p < 0.001) and higher mobilization frequency, with two units/day [IQR 2-2] in the intervention group vs. 0.9 units/day [IQR 0.7-1.0] in the control group (p < 0.001). Interleukin-6 levels decreased significantly by -4.65 pg/mL [IQR -13.00-3.83] in the intervention group vs. an increase of 3.70 pg/ml [IQR -1.30-28.88] in the control group (p = 0.049). CONCLUSIONS: Robotic-assisted mobilization in mechanically ventilated critically ill patients did not reduce required healthcare providers but increased the duration and frequency, and significantly reduced IL-6 levels compared to the standard group. TRIAL REGISTRATION: ClinicalTrials.gov, registration number NCT04423796.

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