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

ICU-acquired Weakness Clinical Trial

— ERP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055949
• Other study ID #: AsanMC-ERP
• Status: Completed
• Phase: N/A
• First received: January 15, 2017
• Last updated: February 14, 2017
• Start date: May 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• ICU-acquired Weakness

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

References & Publications (4)

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. — View Citation

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: 10.101 — View Citation

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 failu — View Citation

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, critic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Time to start rehabilitation from ICU admission (days)		up to 2 weeks
Secondary	ICU delirium days (days)		up to 4 weeks
Secondary	Total rehabilitation days within ICU days (days)		up to 4 weeks
Secondary	ICU readmission rate (%)		up to 24 weeks
Secondary	ICU mortality rate (%)		up to 24 weeks
Secondary	in-hospital mortality rate (%)		up to 24 weeks
Secondary	1 year mortality rate (%)		1 year follow up from ICU admission