Early Directed Physical Therapy in the Management of Mechanically Ventilated Patients in a Medical Intensive Care Unit

The University of Chicago

Status and phase: Completed; Phase 2

Conditions: Mechanically Ventilated Patients

Treatments: Procedure: early PT OT

Study type: Interventional

Funder types: Other

Identifiers

NCT00322010

13766B

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 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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Early PT OT

Experimental group

Description:

Early PT/OT Therapy assessments to begin on the first day that consent is obtained. Therapy is delivered by a team consisting of a physical and occupational therapist and coordinated with daily sedative interruption.

Treatment:

Procedure: early PT OT

Standard Care

No Intervention group

Description:

PT/OT delivered as ordered by the primary ICU team