Early Mobilization in the ICU

University of Chicago200 enrolled

Overview

To study all ICU patients with an independent baseline functional status , who experience a critical illness requiring intubation and mechanical ventilation evaluating long-term cognitive and executive function and long term cost effectiveness in survivors who required mechanical ventilation.

Immediate mobilization of mechanically ventilated (MV) ICU patients is not part of usual care in the U.S. or internationally. Our previous work supports that early mobilization through physical and occupational therapy for ICU patients on the ventilator can help them experience less delirium, spend less time in the ICU and hospital, and become more independent when they leave. To advance our knowledge in this area, large longitudinal studies are needed to understand the long-term physical, cognitive and mental health status of survivors and to test how specific ICU therapies may affect these outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

200

Conditions

Respiratory Failure

Interventions

early PT OTOTHER

1. Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption. 2. active assisted ROM in supine position. 3. treatment is advanced to bed mobility activities 4. sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks. 5. progression to transfer training, and finally pre-gait training and ambulation. 6. progression of activities dependent on patient tolerance and stability 7. therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Intubated and MV \> 24, \< 96 hours * Baseline Barthel Index Functional Score \> 70, functional at home Exclusion Criteria: * Rapidly changing neurological conditions (e.g. stroke) * Cardiac arrest as cause for respiratory failure * Elevated intracranial pressure * Pregnancy (due to inability to provide continuous fetal monitoring) * Terminal condition (life expectancy \< 6 months) * Traumatic brain injury, multiple limb fractures, pelvic fractures, * Severe chronic pain syndrome on admission

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

presence of cognitive impairment

Time frame: within the first 30 days after ICU admission

presence of cognitive impairment

Time frame: up to 1 year post discharge

Secondary Outcomes

cognitive test score

includes variables 1. orientation 2. attention 3. memory 4. reasoning 5. executive function

Time frame: up to 1 year post discharge

institution free days

number of days not requiring inpatient admission

Time frame: up to 1 yr post discharge

Insulin Resistance

Measuring insulin resistance and glycemic control in patients who are still mechanically ventilated on third day of enrollment in the study

Time frame: day 3 of mechanical ventilation

Data from ClinicalTrials.gov

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