Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With Acute Respiratory Failure



Status:Completed
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:8/12/2018
Start Date:October 2009
End Date:June 2015

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Standardized Rehabilitation for ICU Patients With Acute Respiratory Failure

Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the
4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients
with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days,
respectively, with median hospital costs greater than $30,000 United States. Patients with
ARF experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and
reduced health-related quality of life, all of which may contribute to prolonged
hospitalization and increased costs. Mechanistically, it is understood that patients with ARF
demonstrate acute inflammation which may contribute to the above cited problems. While the
investigators' research and that of others has shown that rehabilitation therapy can increase
functional outcomes while lowering biomarkers of inflammation in the frail aged and other
clinical populations, it is not known whether such rehabilitation therapy can result in
improved functional capacity and functional performance and reduce inflammation in ARF
patients. There is previous evidence for the feasibility and safety of rehabilitation therapy
in ARF patients. Therefore, the investigators propose a two-arm, randomized trial in 326
patients with ARF to compare Standardized Rehabilitation Therapy initiated in the ICU and
administered throughout the hospitalization versus usual care (control). Standardized
Rehabilitation Therapy will consist of: passive range of motion, physical therapy and
progressive resistance exercise (strength training). The regimen will be administered 7
days/week by a Mobility Team consisting of a critical care nurse, physical therapist and
nursing assistant.

The investigators will determine whether standardized rehabilitation therapy will reduce
hospital LOS, improve functional capacity and performance, improve quality of life, reduce
inflammation and reduce hospital costs as compared to usual care.

This study's primary objective is to determine whether standardized rehabilitation therapy
will decrease hospital length of stay.

Hypothesis: Compared to usual care, standardized rehabilitation therapy will reduce hospital
length of stay for patients with Acute Respiratory Failure.


Inclusion Criteria:

- Age ≥ 18 years

- Mechanically ventilated via an Endotracheal tube or Bipap

- Lung Injury

Exclusion Criteria:

- Previously enrolled in TARGET STUDY

- Inability to walk without assistance prior to acute ICU illness (use of a cane or
walker not exclusion)

- Cognitive impairment prior to acute ICU illness (non-verbal)

- Acute stroke

- Body mass index (BMI) > 50

- Neuromuscular disease that could impair weaning

- Hip fracture, unstable cervical spine or pathological fracture

- Mechanically ventilated > 80 hours

- Current hospitalization or transferring hospital stay > 7 days

- Ineligible cancer treatment within the last 6 month

- Moribund

- Do Not Resuscitate(DNR)/Do Not Intubate(DNI) on admission

- Other Research Study
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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