Status:
COMPLETED
Investigating Modes of Progressive Mobility
Lead Sponsor:
Hill-Rom
Conditions:
Critical Care
Mechanical Ventilation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the effects of specific activities with and without an early therapeutic mobility (ETM) protocol among patients who experience three or more days of mechanical ...
Detailed Description
The specific aims of this study are to: 1. Compare patient responses to selected modes of therapy (activity) without and with an ETM protocol 1. Molecular responses: markers of inflammation inter...
Eligibility Criteria
Inclusion
- P:F ratio \> 100
- FiO2 \< 60% and PEEP less than 10 cmH20
- hemodynamic stability ten minutes after turning (i.e., heart rate (HR) and/or systolic blood pressure (BP) changes less than 20% of baseline)
- baseline (rest) vitals signs of HR 50-110
- mean arterial pressure (MAP) 60-100 mmHg
- peripheral oxygenation saturation (SpO2) greater than 88%
- Sufficient cognition for progression to levels 2-4 of ETM to assist with out of bed positioning or movement
- a high degree of dependency on others for positioning is acceptable
- there are no exclusions based on gender or minority status.
Exclusion
- End-stage muscular dystrophy
- myasthenia gravis
- new quadriplegia
- coma
- increased intracranial pressure
- unrepaired hip fracture and multiple lower extremity fractures
- Patients experiencing active titration of intravenous vasoactive medications (e.g. dopamine, epinephrine, or norepinepherine) will be excluded
- concurrent use of a continuous lateral rotation bed
- patients for high risk of death will also be excluded
- MICU admission following a hospital stay of \>9 days in the past months
- age \>80 in the presence of 2 or more life-threatening illnesses
- diagnosis of an active stage IV malignancy
- status post cardiac arrest
- diagnosis of intracerebral hemorrhage requiring mechanical ventilation
- subjects over 400 pounds can be excluded from mobilization based on the judgment of the bedside nurse or project manager; if the risk for staff or patient harm from moving a patient with excessive weight is considered likely, mobilization will not occur.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00787098
Start Date
November 1 2007
End Date
July 1 2009
Last Update
July 3 2009
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