Safety and Efficacy of an Early Rehabilitation Program in Surgical Intensive Care Unit

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.

Official Title
-----------------
Safety and Efficacy of an Early Rehabilitation Program in Surgical Intensive Care Unit (SICU)

Conditions
-----------------
ICU-acquired Weakness

Intervention / Treatment
-----------------
* Behavioral: Early rehabilitation program


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: pre-ERP<br>A group of the surgical ICU patients who had standard care before Asan medical center developed an early rehabilitation program (ERP) | |
| Experimental: post-ERP<br>A group of the surgical ICU patients who had an early rehabilitation program (ERP) within SICU care | Behavioral: Early rehabilitation program<br>* The investigators evaluated patients who were admitted SICU for more than 3 days for an early rehabilitation program and delivered one of 5-stepped rehabilitation program if the patient was eligible.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day Ventilator-free days (days) | Patients who died during the study were assigned scores of 0 for 28-day ventilator-free days. | up to 28-day | 
| 28-day ICU-free days (days) | Patients who died during the study were assigned scores of 0 for 28-day ICU-free days | up to 28-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early rehabilitation, early mobilization, surgical intensive care unit