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

Mechanically Ventilated Patients Clinical Trial

Official title:

A Randomized Trial of Early Physical and Occupational Therapy in Mechanically Ventilated, Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322010
• Other study ID #: 13766B
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2006
• Last updated: March 17, 2014
• Start date: June 2005
• Est. completion date: October 2007

Study information

• Verified date: March 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mechanically Ventilated Patients

Intervention

Procedure:
• early PT OT
Passive range of motion exercises for all limbs in patients who remain unresponsive despite sedative interruption (ten repetitions in all cardinal directions). Sessions began with active assisted and active range of motion exercises in the supine position. If tolerated, treatment is advanced to bed mobility activities, including transferring to upright sitting. Sitting balance activities are followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks. The session progresses to transfer training, and finally pre-gait exercises and ambulation. Progression of activities is dependent on patient tolerance and stability. 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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of hospital days with delirium		Hospital discharge	No
Secondary	Number of days alive and breathing without assistance (ventilator-free days)		during 28-day study period	No
Secondary	length of stay		ICU and Hospital discharge	No