Mechanical Ventilation Clinical Trial
Official title:
Investigating Modes of Progressive Mobility
Verified date | July 2009 |
Source | Hill-Rom |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 ventilation. A second purpose is to examine staff/delivery system and patient factors that influence the initiation and progression of activity with and without an ETM protocol. The hypothesis is that ETM protocols will result in improved patient outcomes.
Status | Completed |
Enrollment | 82 |
Est. completion date | July 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hill-Rom |
Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare immediate molecular and physiological patient responses to activity with responses to an ETM protocol. | 1, 2, 3, 7, days then weekly | No | |
Secondary | A secondary aim is to identify strategies and conditions that promote or prevent ETM. | 1, 3, 5, 7, days then weekly | No |
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