A Study Promoting Critical Illness Recovery in the Elderly (ASPIRE)
Acute Respiratory Distress Syndrome, Critical Illness, Critical Care
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- Age ≥55 years old
- Admission to Wake Forest Baptist Medical Center Medical Intensive Care Unit
- Acute Hypoxic respiratory failure on mechanical ventilation for <48 hours with a P:F ratio of <300 (or equivalent S:F ratio)
- Previously Functional (over past 3 months, as reported by proxy):
Physical Function: Able to walk 4 m (with or without assistive device)
Exclusion Criteria:
- Neuromuscular Disease
- Cardiopulmonary Arrest with return of spontaneous circulation <6 hrs
- Palliative Goals of Care; witholding life-sustaining therapy
- Elevated Intracranial Pressure (>20 mm Hg)
- BMI>45; absolute weight >= 150 kg
- Inability to cycle (including absent limbs, body length <1.5m, body habitus not fitting the cycle, inflammatory arthritis, significant joint problems including inability to bend arms/legs; pelvic and/or LE fracture, LE bypass surgery)
- Pregnancy
- Unable to speak English
- Use of continuous neuromuscular blockade
- Temporary Pacemaker or Swan Ganz catheter or femoral ECMO catheter/IABP
- Rhabdomyolysis with most recent CK >5000
- Clinical diagnosis of dementia on medication
- Moribund
- Possible Exclusion: If the patient is on spine precautions, a discussion with the spine team will be necessary to determine eligibility for the study
Sites / Locations
- Atrium Health Wake Forest Baptist
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention
Usual Care
The intervention group will receive in-bed cycle ergometry within 48 hours of randomization if safety criteria are met. The intervention arm will receive early physical therapy (PT). This PT will be performed according to a protocol of additional ICU and hospital-administered rehabilitation strategies that have been previously developed. Patients will receive 30 minutes of PT at least 5 times per week while conscious. If unconscious, subjects will only receive passive range of motion (PROM) for 10 repetitions per body part daily. Once conscious, subjects will progress through PT with an emphasis on ambulation. Therapy for the intervention arm patients will continue while on the floor. Outpatient therapy will be provided at the discretion of the patient's treating physicians.
The control group will receive usual care physical therapy as ordered by the treating team both in the ICU and on the floor through hospital discharge. These subjects will also receive therapy as outpatients only as ordered by their regular physicians.