Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure



Status:Completed
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:8/17/2018
Start Date:July 2007
End Date:August 2009

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Effect Of Acute Inflammatory Mediators On Duration Of Functional Limitations In Patients With Acute Respiratory Failure, A Randomized, Controlled Pilot Study of Early ICU Rehabilitation Strategies

This is a randomized, controlled, pilot study of two separate Cohorts of patients from the
intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical
therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50
patients and randomize to receive either two physical therapy sessions per day or usual care.
Outcome will be length of hospital stay measured in days. Secondary outcomes will be
mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength
assessments and the short physical performance battery (SPPB). Study subjects will have blood
for cytokine analysis through their first week of study.


Inclusion Criteria:

• Mechanically ventilated via an endotracheal tube or mask

Exclusion Criteria:

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

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

- Preadmit immunocompromised (>prednisone 20 mg/d for 2 wks)

- Acute stroke

- Body mass index (BMI) >45

- Neuromuscular disease that could impair weaning (myasthenia gravis, ALS,
Guillain-Barre)

- Hip fracture, unstable cervical spine or pathological fracture

- Mech vent >48 hours prior to transfer from an outside facility

- Current hospitalization or transferring hospital stay >72 hours

- CPR on admission, DNR on admission

- Hospitalization within 30 days prior to admission

- Cancer therapy within last 6 months

- Re-admission to ICU within current hospitalization
We found this trial at
1
site
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
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