Early Mobilization in the ICU

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT01777035
Collaborator
(none)
200
1
2
125.9
1.6

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: early PT OT
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Early Mobilization in the ICU
Actual Study Start Date :
Jul 19, 2011
Actual Primary Completion Date :
Jan 14, 2022
Actual Study Completion Date :
Jan 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Early physical therapy(PT) occupational therapy (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
Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption. active assisted ROM in supine position. treatment is advanced to bed mobility activities sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks. progression to transfer training, and finally pre-gait training and ambulation. progression of activities dependent on patient tolerance and stability 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

Outcome Measures

Primary Outcome Measures

  1. presence of cognitive impairment [within the first 30 days after ICU admission]

  2. presence of cognitive impairment [up to 1 year post discharge]

Secondary Outcome Measures

  1. cognitive test score [up to 1 year post discharge]

    includes variables orientation attention memory reasoning executive function

  2. institution free days [up to 1 yr post discharge]

    number of days not requiring inpatient admission

  3. Insulin Resistance [day 3 of mechanical ventilation]

    Measuring insulin resistance and glycemic control in patients who are still mechanically ventilated on third day of enrollment in the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

  • Principal Investigator: John P Kress, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT01777035
Other Study ID Numbers:
  • 11-0218
First Posted:
Jan 28, 2013
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022

Study Results

No Results Posted as of Feb 21, 2022