Early Mobilization in the ICU

The University of Chicago

Status: Completed

Conditions: Respiratory Failure

Treatments: Other: early PT OT

Study type: Interventional

Funder types: Other

Identifiers

NCT01777035

11-0218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Early physical therapy(PT) occupational therapy (OT)

Experimental group

Description:

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

Treatment:

Other: early PT OT

standard care

No Intervention group

Description:

PT OT delivered as ordered by the primary ICU team