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

Wake Forest University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Acute Respiratory Failure

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Hospital length of stay, days

Hospital stay measured in days.

Time frame: The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.