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

Wake Forest University (WFU)

Status: Completed

Conditions: Acute Respiratory Failure

Treatments: Other: Early ICU rehabilitation strategies; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01707303

IRB00000240

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Usual Care

Other group

Description:

Usual hospital rehabilitative services

Treatment:

Other: Usual Care

Early ICU Rehabilitation Strategy

Experimental group

Description:

Early ICU physical therapy will be applied in this arm

Treatment:

Other: Early ICU rehabilitation strategies