Mechanically Ventilated Patients
Conditions
Keywords
mechanical ventilation, physical therapy, occupational therapy, mobilization, clinical protocols, ICU acquired weakness, critical illness myopathy, muscle atrophy, intensive care unit, randomized controlled trial
Brief summary
To study all ICU patients with an independent baseline functional status, who experience a critical illness requiring intubation and mechanical ventilation, evaluating the role of protocol-directed, early physical and occupational therapy on the incidence of critical illness associated functional debilitation. Our goal is to hasten the recovery of independent physical functioning as well as to reduce ICU delirium in the group of patients who begin this intervention from the earliest hours of ventilator dependence.
Interventions
PROCEDUREearly PT OT
1. Passive range of motion exercises for all limbs in patients who remain unresponsive despite sedative interruption (ten repetitions in all cardinal directions). 2. Sessions began with active assisted and active range of motion exercises in the supine position. 3. If tolerated, treatment is advanced to bed mobility activities, including transferring to upright sitting. 4. Sitting balance activities are followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks. 5. The session progresses to transfer training, and finally pre-gait exercises and ambulation. 6. Progression of activities is dependent on patient tolerance and stability. 7. Therapy intervention continues on a daily basis throughout the patient's hospital stay until he/she returns to prior level of function or is discharged.
Sponsors
University of Iowa
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
1. Patients intubated and mechanical ventilated for \< 72 hours 2. Age \> 18 years 3. Baseline independent functional status as assessed by a Barthel Index score \> 70 collected from a proxy reflecting baseline health 2 weeks prior to critical illness
Exclusion criteria
1. Rapidly evolving neurological/neuromuscular disease 2. Cardiac arrest 3. Irreversible conditions with six month mortality estimated at \> 50% 4. Elevated intracranial pressure 5. Multiple absent limbs (precluding complete musculoskeletal examination) 6. Enrollment in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients returning to independent functional status: defined as ability to perform 6 activities of daily living (ADL's)(bathing, dressing, eating, grooming, transfer from bed to chair, toileting) and independent ambulation | Hospital Discharge |
Secondary
| Measure | Time frame |
|---|---|
| Number of hospital days with delirium | Hospital discharge |
| Number of days alive and breathing without assistance (ventilator-free days) | during 28-day study period |
| length of stay | ICU and Hospital discharge |
Countries
United States
Outcome results
None listed