Efficacy And Safety of Family Participate In The Early Mobilization of Critically Ill Patients: Study Protocol For A Randomized Controlled Trial

Abstract Background：Long-term immobilization can cause a series of harm to ICU patients, while early rehabilitation can effectively reduce the harm of long-term immobilization and improve the medical outcome of patients. Can family members participate in the early mobilization (FMPiEM) of critically ill patients? Whether the FMPiEM of critically ill patients can reduce delirium, anxiety, depression, post-traumatic stress syndrome and other adverse emotions of ICU patients.Objective: To explore the FMPiEM of critically ill patients on the short-term and long-term outcomes.Methods and design: A single-center randomized controlled trial (RCT) is conducted and reported according to the CONSORT guidelines. A total of 120 samples were randomly assigned to the intervention group (FMPiEM) and the control group ( without-FMPiEM).The primary outcome indicators included the incidence of ICU delirium, acquired infection, ICU mortality, and ICU-acquired weakness (ICU-AW), while the secondary outcome indicators included mechanical ventilation time, length of stay in ICU (ICU LOS), reintubation, unplanned extubation (UEX), hospitalization costs, and patient outcomes. SPSS 22.0 software was used for statistical analysis. Frequency and mean ± standard deviation were used for descriptive analysis. B test, t test or Mann-whitney U test were used for statistical inference.Discussion: FMPiEM of critically ill patients maybe not only reduce the incidence of delirium, ICU-AW, but also reduce the mechanical ventilation time, length of stay in ICU, reintubation, UEX and hospitalization costs of critically ill patients, at the same time, without increasing the acquired infection in ICU.Trial registration: Chinese Clinical Trial Registry, ID:ChiCTR2000028902. Registered on 06 January 2020.