Respiratory Failure
Conditions
Keywords
mechanical ventilation, physical therapy, occupational therapy, ICU acquired weakness, critical illness myopathy
Brief summary
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.
Detailed description
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.
Interventions
OTHERearly PT OT
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.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| presence of cognitive impairment | within the first 30 days after ICU admission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cognitive test score | up to 1 year post discharge | includes variables 1. orientation 2. attention 3. memory 4. reasoning 5. executive function |
| institution free days | up to 1 yr post discharge | number of days not requiring inpatient admission |
| Insulin Resistance | day 3 of mechanical ventilation | Measuring insulin resistance and glycemic control in patients who are still mechanically ventilated on third day of enrollment in the study |
Countries
United States
Outcome results
None listed