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OpenTrials
Completed

NCT Number: NCT01777035

Early Mobilization in the ICU

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.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early PT OT

Other
  • 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.

Primary outcomes

  1. presence of cognitive impairment

    Time frame: within the first 30 days after ICU admission

  2. presence of cognitive impairment

    Time frame: up to 1 year post discharge

Secondary outcomes

  1. cognitive test score

    Time frame: up to 1 year post discharge

    includes variables

    • orientation
    • attention
    • memory
    • reasoning
    • executive function

  2. institution free days

    Time frame: up to 1 yr post discharge

    number of days not requiring inpatient admission

  3. Insulin Resistance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2013
Registry last updated
Feb 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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