Early Mobilization in the ICU

Study Overview
=================
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.

Official Title
-----------------
Early Mobilization in the ICU

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Other: early PT OT


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early physical therapy(PT) occupational therapy (OT)<br>Early PT OT assessments begin on first day of study. Therapy delivered by a team consisting of physical and occupational therapists and coordinated with daily sedative interruption | Other: early PT OT<br>* Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption. active assisted ROM in supine position. treatment is advanced to bed mobility activities sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks. progression to transfer training, and finally pre-gait training and ambulation. progression of activities dependent on patient tolerance and stability therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged.<br>|
| No Intervention: standard care<br>PT OT delivered as ordered by the primary ICU team | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of cognitive impairment |  | within the first 30 days after ICU admission | 
| presence of cognitive impairment |  | up to 1 year post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive test score | includes variables orientation attention memory reasoning executive function | up to 1 year post discharge | 
| institution free days | number of days not requiring inpatient admission | 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 | day 3 of mechanical ventilation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, physical therapy, occupational therapy, ICU acquired weakness, critical illness myopathy