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Completed

NCT Number: NCT03055949

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Early rehabilitation program

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.

Primary outcomes

  1. 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.

  2. 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

  1. Time to start rehabilitation from ICU admission (days)

    Time frame: up to 2 weeks

  2. ICU delirium days (days)

    Time frame: up to 4 weeks

  3. Total rehabilitation days within ICU days (days)

    Time frame: up to 4 weeks

  4. ICU readmission rate (%)

    Time frame: up to 24 weeks

  5. ICU mortality rate (%)

    Time frame: up to 24 weeks

  6. in-hospital mortality rate (%)

    Time frame: up to 24 weeks

  7. 1 year mortality rate (%)

    Time frame: 1 year follow up from ICU admission

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Acronym: ERP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 16, 2017
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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