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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Other: early PT OT

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
presence of cognitive impairment	within the first 30 days after ICU admission
presence of cognitive impairment	up to 1 year post discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive test score	includes variables; orientation; attention; memory; reasoning; executive function	up to 1 year post discharge
institution free days	number of days not requiring inpatient admission	up to 1 yr post discharge
Insulin Resistance	Measuring insulin resistance and glycemic control in patients who are still mechanically ventilated on third day of enrollment in the study	day 3 of mechanical ventilation

Collaborators and Investigators

• Sponsor: University of Chicago

Publications and helpful links

General Publications

• Wolfe KS, Patel BK, MacKenzie EL, Giovanni SP, Pohlman AS, Churpek MM, Hall JB, Kress JP. Impact of Vasoactive Medications on ICU-Acquired Weakness in Mechanically Ventilated Patients. Chest. 2018 Oct;154(4):781-787. doi: 10.1016/j.chest.2018.07.016. Epub 2018 Sep 11.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2011
• Primary Completion (Actual): January 14, 2022
• Study Completion (Actual): January 14, 2022

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 23, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: mechanical ventilation; physical therapy; occupational therapy; ICU acquired weakness; critical illness myopathy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 11-0218