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

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

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.

Study Overview

• Status: Completed
• Conditions: ICU-acquired Weakness
• Intervention / Treatment: Behavioral: Early rehabilitation program

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 Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: pre-ERP; A group of the surgical ICU patients who had standard care before Asan medical center developed an early rehabilitation program (ERP)
Experimental: post-ERP; A group of the surgical ICU patients who had an early rehabilitation program (ERP) within SICU care	Behavioral: Early rehabilitation program; 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.

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	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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Suk-kyung Hong, Ph.D., Asan Medical Center

Publications and helpful links

General Publications

• Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. doi: 10.1097/01.CCM.0000251130.69568.87.
• McWilliams D, Weblin J, Atkins G, Bion J, Williams J, Elliott C, Whitehouse T, Snelson C. Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: a quality improvement project. J Crit Care. 2015 Feb;30(1):13-8. doi: 10.1016/j.jcrc.2014.09.018. Epub 2014 Oct 2.
• Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
• Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: February 14, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: early mobilization; early rehabilitation; surgical intensive care unit
• Other Study ID Numbers: AsanMC-ERP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No