Early Mobilization in the ICU

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Other: early PT OT

• Registration Number: NCT01777035
• Lead Sponsor: University of Chicago

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07-19
• Study First Submitted: 2013-01-16
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Intubated and MV > 24, < 96 hours
• Baseline Barthel Index Functional Score > 70, functional at home

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early physical therapy(PT) occupational therapy (OT)	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

Primary Outcome Measures

Name	Time	Method
presence of cognitive impairment	up to 1 year post discharge

Secondary Outcome Measures

Name	Time	Method
cognitive test score	up to 1 year post discharge	includes variables; 1. orientation; 2. attention; 3. memory; 4. reasoning; 5. executive function
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
institution free days	up to 1 yr post discharge	number of days not requiring inpatient admission

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States