Safety and Efficacy of an Early Rehabilitation Program in Surgical Intensive Care Unit (SICU)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 131
- Primary Endpoint
- 28-day Ventilator-free days (days)
Study Overview
Brief Summary
The purpose of this study is to determine whether an early rehabilitation program in surgical intensive care unit is safe and effective in preventing critical care illness and intensive care unit acquired weakness.
Detailed Description
Due to the complications like intensive care unit-acquired weakness, critical illness polyneuropathy and neuropsychiatric disease of critical care, many organizations focus on rehabilitation in critically ill patients' management. Despite the good outcomes from papers, there are debatable issues of method, safety and efficacy of rehabilitation. The investigators developed an early rehabilitation program (ERP) in our surgical ICU management and assessed safety and efficacy of it.
The ERP started in November 2014 in our 14-bed surgical ICU in Asan Medical Center. The investigators focused on early and 5-step rehabilitation program for patients who were admitted to SICU for at least 3 days. The investigators enrolled 69 patients (pre-ERP group) for 6 months before November 2014 and 62 patients (post-ERP group) for 6 months 1 year after the ERP started. The main measures were safety issues, delirium days, 28-d ventilator free-days, 28-d ICU free-days, hospital length of stay (LOS), ICU mortality, in-hospital mortality and 1 year mortality.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who were admitted in SICU for at least 3 days
Exclusion Criteria
- •readmission to SICU within current hospitalization open abdomen wound patients major bone fracture patients brain death patients active bleeding patients increased intra-cranial pressure patients paraplegic patients patients or their guardians did not agree with the ERP doctor's decision (Deconditioning patients, Procedure)
Arms & Interventions
pre-ERP
A group of the surgical ICU patients who had standard care before Asan medical center developed an early rehabilitation program (ERP)
post-ERP
A group of the surgical ICU patients who had an early rehabilitation program (ERP) within SICU care
Intervention: Early rehabilitation program (Behavioral)
Outcomes
Primary Outcomes
28-day Ventilator-free days (days)
Time Frame: up to 28-day
Patients who died during the study were assigned scores of 0 for 28-day ventilator-free days.
28-day ICU-free days (days)
Time Frame: up to 28-day
Patients who died during the study were assigned scores of 0 for 28-day ICU-free days
Secondary Outcomes
- Time to start rehabilitation from ICU admission (days)(up to 2 weeks)
- ICU delirium days (days)(up to 4 weeks)
- Total rehabilitation days within ICU days (days)(up to 4 weeks)
- ICU readmission rate (%)(up to 24 weeks)
- ICU mortality rate (%)(up to 24 weeks)
- in-hospital mortality rate (%)(up to 24 weeks)
- 1 year mortality rate (%)(1 year follow up from ICU admission)
Investigators
Suk-Kyung
Associate professor
Asan Medical Center