Evaluation of safety and clinical effectiveness of early rehabilitation for Critical ill children in PICU

Research Objectives: To determine the safety and feasibility of an early mobilization program in a pediatric intensive care unit

Design: Randomized Controlled Trial design

Setting: PICU in a single tertiary medical center in South Korea

Participants: Children aged 1-18 years

Interventions: This study was conducted with the control group undergoing simple rehabilitation (passive range of motion) once a day, while the intervention group underwent rehabilitation therapy twice a day.

Main Outcome Measures: This study estimated incidence of adverse events such as hemodynamic change (heart rate, oxygen saturation fluctuation) and removal of medical devices etc. In order to evaluate clinical efficacy, functional status through the functional status score (FSS), occupational function through tools like PEDI CAT as well as assessments of parental anxiety. Additionally, we measured patient quality of life using the Pediatric Quality of Life Inventory version 4.0.

Results: 61 patients have been enrolled, with 33 in the intervention group and 28 in the control group. A total of 769 rehabilitation therapy sessions were conducted . There were no reported adverse events including medical devices dislodges, falls etc. In the intervention group, there was a lower occurrence of significant changes in overall vital signs compared to the control group. We observed differences in the FSS based on time and groups. In terms of the parental anxiety scale, both groups showed improvement.

Conclusions: Early rehabilitation in the PICU appears to be secure, characterized by a minimal occurrence of safety-related issues. The intervention group displayed a notably reduced frequency of hemodynamic adverse events in comparison to the control group. These findings imply that the probability of adverse events diminishes as the frequency of rehabilitation therapy increases, particularly in patients familiar with the therapist. Early rehabilitation therapy appears to be effective in enhancing patients' functional aspects and alleviating parental anxiety factors.

Author(s) Disclosures: This study was supported by the National Research Foundation of Korea grant funded by the Korea government. (No.2020R1A2C1013587) The authors have stated that they had no interests which might be perceived as posing a conflict or bias.