The aim of this study is to clarify the incidence and risk factors of patient-related safety events (PSE) in situations limited to intubated patients in which active mobilization, such as sitting on the edge of the bed/standing/walking, was carried out. A multi-center retrospective observational study was conducted at nine hospitals between January 2017 and March 2018. The safety profiles and PSE of 87 patients were analyzed. PSE occurred in 10 out of 87 patients (11.5%) and 13 out of 198 sessions (6.6%). The types of PSE that occurred were hypotension (8, 62%), heart rate instability (3, 23%), and desaturation (2, 15%). Circulation-related events occurred in 85% of overall cases. No accidents, such as line/tube removal or falls, were observed. The highest incidence of PSE was observed during the mobilization level of standing (8 out of 39 sessions, 20.5%). The occurrence of PSE correlated with the highest activity level under logistic regression analysis. Close vigilance is required for intubated patients during active mobilization in the standing position with regard to circulatory dynamics.

IntroductionSepsis is not only the leading cause of death in the intensive care unit (ICU) but also a major risk factor for physical and cognitive impairment and mental disorders, known as postintensive care syndrome (PICS), reduced health-related quality of life (HRQoL) and even mental health disorders in patient families (PICS-family; PICS-F). The ABCDEF bundle is strongly recommended to overcome them, while the association between implementing the bundle and the long-term outcomes is also unknown.Methods and analysisThis is a multicentre prospective observational study at 26 ICUs. All consecutive patients between 1 November 2020 and 30 April 2022, who are 18 years old or older and expected to stay in an ICU for more than 48 hours due to sepsis or septic shock, are enrolled. Follow-up to evaluate survival and PICS/ PICS-F will be performed at 3, 6 and 12 months and additionally every 6 months up to 5 years after hospital discharge. Primary outcomes include survival at 12 months, which is the primary outcome, and the incidence of PICS defined as the presence of any physical impairment, cognitive impairment or mental disorders. PICS assessment scores, HRQoL and employment status are evaluated. The association between the implementation rate for the ABCDEF bundle and for each of the individual elements and long-term outcomes will be evaluated. The PICS-F, defined as the presence of mental disorders, and HRQoL of the family is also assessed. Additional analyses with data up to 5 years follow-up are planned.Ethics and disseminationThis study received ethics approvals from Saiseikai Utsunomiya Hospital (2020-42) and all other participating institutions and was registered in the University Hospital Medical Information Network Clinical Trials Registry. Informed consent will be obtained from all patients. The findings will be published in peer-reviewed journals and presented at scientific conferences.Trial registration numberUMIN000041433.

This is a prospective multicenter cohort study aiming to investigate the association between early mobilization (EM), defined as a rehabilitation level of sitting at the edge of the bed or higher within 72 h of ICU admission, and psychiatric outcome. Consecutive patients, admitted to the ICU for more than 48 h, were enrolled. The primary outcome was the incidence of psychiatric symptoms at 3 months after hospital discharge defined as the presence of any of three symptoms: depression, anxiety, or post-traumatic stress disorder (PTSD). Risk ratio (RR) and multiple logistic regression analysis were used. As a sensitivity analysis, two methods for inverse probability of treatment weighting statistics were performed. Of the 192 discharged patients, 99 (52%) were assessed. The patients who achieved EM had a lower incidence of psychiatric symptoms compared to those who did not (25% vs. 51%, p-value 0.008, odds ratio (OR) 0.27, adjusted p = 0.032). The RR for psychiatric symptoms in the EM group was 0.49 [95% Confidence Interval, 0.29–0.83]. Sensitivity analysis accounting for the influence of death, loss to follow-up (OR 0.28, adjusted p = 0.008), or potential confounders (OR 0.49, adjusted p = 0.046) consistently showed a lower incidence of psychiatric symptoms in the EM group. EM was consistently associated with fewer psychiatric symptoms.