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Early Mobilization in the ICU

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John Kress, University of Chicago
ClinicalTrials.gov Identifier:
NCT01777035
First received: January 16, 2013
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Respiratory Failure
 Other: early PT OT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Mobilization in the ICU

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • presence of cognitive impairment [ Time Frame: within the first 30 days after ICU admission ] [ Designated as safety issue: No ]
  • presence of cognitive impairment [ Time Frame: up to 1 year post discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cognitive test score [ Time Frame: up to 1 year post discharge ] [ Designated as safety issue: No ]

    includes variables

    1. orientation
    2. attention
    3. memory
    4. reasoning
    5. executive function

  • institution free days [ Time Frame: up to 1 yr post discharge ] [ Designated as safety issue: No ]
    number of days not requiring inpatient admission


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early PT OT
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
 Other: early PT OT
  1. Passive ROM in pts who remain unresponsive despite sedative interruption.
  2. active assisted ROM in supine position.
  3. treatment is advanced to bed mobility activities
  4. sitting balance activities followed by participation in ADLs and exercises that encourage increased independence with functional tasks.
  5. progression to transfer training, and finally pre-gait training and ambulation.
  6. progression of activities dependent on patient tolerance and stability
  7. therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged.
No Intervention: standard care
PT OT delivered as ordered by the primary ICU team

Detailed Description:

Immediate mobilization of 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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777035

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: John P Kress, MD University of Chicago
  More Information

No publications provided

Responsible Party: John Kress, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01777035     History of Changes
Other Study ID Numbers: 11-0218
Study First Received: January 16, 2013
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
mechanical ventilation
physical therapy
occupational therapy
ICU acquired weakness
critical illness myopathy

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013