Clinical trial NCT03055949: Safety and Efficacy of an Early Rehabilitation Program in Surgical Intensive Care Unit
Official title: Safety and Efficacy of an Early Rehabilitation Program in Surgical Intensive Care Unit (SICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICU-acquired Weakness
Keywords: early rehabilitation
early mobilization
surgical intensive care unit
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: 28-day Ventilator-free days (days)
timeFrame: up to 28-day
measure: 28-day ICU-free days (days)
timeFrame: up to 28-day
Secondary outcomes:
measure: Time to start rehabilitation from ICU admission (days)
timeFrame: up to 2 weeks
measure: ICU delirium days (days)
timeFrame: up to 4 weeks
measure: Total rehabilitation days within ICU days (days)
timeFrame: up to 4 weeks
measure: ICU readmission rate (%)
timeFrame: up to 24 weeks
measure: ICU mortality rate (%)
timeFrame: up to 24 weeks
measure: in-hospital mortality rate (%)
timeFrame: up to 24 weeks
measure: 1 year mortality rate (%)
timeFrame: 1 year follow up from ICU admission
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Suk-kyung Hong, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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: 10.1016/j.jcrc.2014.09.018. Epub 2014 Oct 2.
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 failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
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, 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.