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Early Mobilization in the ICU

Primary Purpose

Respiratory Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

early PT OT

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring mechanical ventilation, physical therapy, occupational therapy, ICU acquired weakness, critical illness myopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early physical therapy(PT) occupational therapy (OT)

standard care

Arm Description

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

PT OT delivered as ordered by the primary ICU team

Outcomes

Primary Outcome Measures

presence of cognitive impairment

Secondary Outcome Measures

cognitive test score

includes variables orientation attention memory reasoning executive function

institution free days

number of days not requiring inpatient admission

Insulin Resistance

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

Full Information

NCT ID

NCT01777035

First Posted

January 16, 2013

Last Updated

February 17, 2022

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT01777035

Brief Title

Early Mobilization in the ICU

Official Title

Early Mobilization in the ICU

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

July 19, 2011 (Actual)

Primary Completion Date

January 14, 2022 (Actual)

Study Completion Date

January 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure

Keywords

mechanical ventilation, physical therapy, occupational therapy, ICU acquired weakness, critical illness myopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early physical therapy(PT) occupational therapy (OT)

Arm Type

Experimental

Arm Description

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

Arm Title

standard care

Arm Type

No Intervention

Arm Description

PT OT delivered as ordered by the primary ICU team

Intervention Type

Other

Intervention Name(s)

early PT OT

Intervention Description

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 Outcome Measure Information:

Title

presence of cognitive impairment

Time Frame

within the first 30 days after ICU admission

Title

presence of cognitive impairment

Time Frame

up to 1 year post discharge

Secondary Outcome Measure Information:

Title

cognitive test score

Description

includes variables orientation attention memory reasoning executive function

Time Frame

up to 1 year post discharge

Title

institution free days

Description

number of days not requiring inpatient admission

Time Frame

up to 1 yr post discharge

Title

Insulin Resistance

Description

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

Time Frame

day 3 of mechanical ventilation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John P Kress, MD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30217640

Citation

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.

Results Reference

derived

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Early Mobilization in the ICU

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