Early Mobilization in the ICU

Respiratory Failure Clinical Trial

Official title:

Early Mobilization in the ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777035
• Other study ID #: 11-0218
• Status: Completed
• Phase: N/A
• Start date: July 19, 2011
• Est. completion date: January 14, 2022

Study information

• Verified date: February 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of cognitive impairment		within the first 30 days after ICU admission
Primary	presence of cognitive impairment		up to 1 year post discharge
Secondary	cognitive test score	includes variables; orientation; attention; memory; reasoning; executive function	up to 1 year post discharge
Secondary	institution free days	number of days not requiring inpatient admission	up to 1 yr post discharge
Secondary	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