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Clinical Trials/NCT03055949
NCT03055949
Completed
N/A

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

Asan Medical Center0 sites131 target enrollmentMay 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
ICU-acquired Weakness
Sponsor
Asan Medical Center
Enrollment
131
Primary Endpoint
28-day Ventilator-free days (days)
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Suk-Kyung

Associate professor

Asan Medical Center

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)

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

  • in-hospital mortality rate (%)(up to 24 weeks)
  • 1 year mortality rate (%)(1 year follow up from ICU admission)
  • 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)

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