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

NCT ID: NCT03055949

Last Updated: 2017-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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ICU-acquired Weakness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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pre-ERP

A group of the surgical ICU patients who had standard care before Asan medical center developed an early rehabilitation program (ERP)

Group Type NO_INTERVENTION

No interventions assigned to this group

post-ERP

A group of the surgical ICU patients who had an early rehabilitation program (ERP) within SICU care

Group Type EXPERIMENTAL

Early rehabilitation program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Suk-Kyung

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suk-kyung Hong, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

References

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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.

Reference Type RESULT
PMID: 17133183 (View on PubMed)

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.

Reference Type RESULT
PMID: 25316527 (View on PubMed)

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.

Reference Type RESULT
PMID: 18596631 (View on PubMed)

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.

Reference Type RESULT
PMID: 19446324 (View on PubMed)

Other Identifiers

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AsanMC-ERP

Identifier Type: -

Identifier Source: org_study_id

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