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

This study is currently recruiting participants.

Verified by University of Chicago, August 2007

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00322010

Purpose

We propose to study all patients with an independent baseline functional status, who experience a critical illness requiring intubation and mechanical ventilation, evaluating the role of a protocol-directed, early physical therapy and "animation" strategy on the incidence of critical illness associated weakness or CINMA. Our goal is to hasten the recovery of independent functioning in the group of patients who begin this intervention from the earliest hours of ventilator dependence.

Condition	Intervention
Mechanically Ventilated Patients	Behavioral: Functional Independence achieved

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind, Active Control, Factorial Assignment
Official Title:	Early Directed Physical Therapy in the Management of Mechanically Ventilated Patients in a Medical Intensive Care Unit

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Neuro muscular weakness (NMW) as measured by clinical exam & hand grip monitor
Ability to perform activities of daily living (ADL's)
ICU DC strength testing
Hospital DC strength testing
Blood testing for NMW markers
6 month follow up - mortality, ability to perform ADL's, return to work

Estimated Enrollment:	70
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Patients intubated and mechanical ventilated for < 72 hours 2. Age > 18 years 3. Baseline independent functional status as assessed by activities of daily living (ADL's)
1. ADL's include bathing, dressing, transferring from bed or chair, walking, eating, toilet use, grooming

Exclusion Criteria:

1. Rapidly evolving neurological disease 2. Cardiac arrest as cause for respiratory failure. 3. Elevated intracranial pressure. 4. Multiple absent limbs (precluding complete musculoskeletal examination) 5. Advanced dementia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322010

Contacts

Contact: JP Kress, MD	773-702-6790	jkress@medicine.bsd.uchicago.edu
Contact: Anne Pohlman, RN	773-702-3804	apohlman@medicine.bsd.uchicago.edu

Locations

United States, Illinois
University of Chicago	Recruiting
Chicago, Illinois, United States, 60637
Contact: Anne Pohlman, RN 773-702-3804 apohlman@medicine.bsd.uchicago.edu
Principal Investigator: JP Kress, MD

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator:

JP Kress, MD

University of Chicago

More Information

Study ID Numbers:	13766B
Study First Received:	May 2, 2006
Last Updated:	August 9, 2007
ClinicalTrials.gov Identifier:	NCT00322010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

Mechanically Ventilated, physiologic, derangement

ClinicalTrials.gov processed this record on January 14, 2009