Status:
COMPLETED
Dose of Early Therapeutic Mobility: Does Type or Frequency Matter?
Lead Sponsor:
Case Western Reserve University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
MetroHealth Medical Center
Conditions:
Critical Illness
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This study will examine the effects of once and twice daily activity performed with patients who are breathing with the aid of a machine in an intensive care unit. Activity can occur in bed. Activity ...
Detailed Description
Early therapeutic mobility (ETM) activity has been recommended to facilitate recovery and improve outcomes for the survivors of critical illness who experience prolonged mechanical ventilation. The ef...
Eligibility Criteria
Inclusion
- Adult patients who require invasive mechanical ventilation for more than 24 continuous hours in the surgical (SICU) or medical ICU (MICU)
- a P:F ratio \> 100
- FiO2 \< 60% and PEEP less than 10 cmH20 at baseline
- resting vital signs of HR 50-110, mean arterial pressure (MAP) 60-110 mmHg, peripheral oxygenation saturation (SpO2) greater than 88%.
Exclusion
- There are no exclusions based on gender or minority status.
- Patients will be excluded if they have pre-existing or current neurological, muscular or orthopedic disorders that require inactivity or immobilization during acute care or experience paresis/paralysis that will not improve. Examples of exclusionary conditions include end-stage muscular dystrophy, myasthenia gravis, new quadriplegia, coma, increased intracranial pressure, unrepaired hip fracture and multiple lower extremity fractures.
- Patients for high risk of death will also be excluded, using criteria established by Norton et al.: ICU admission following a hospital stay of \>9 days in the past 12 months; age \>80 in the presence of 2 or more life-threatening illnesses (e.g., end-stage renal disease, severe heart failure (HF); diagnosis of an active stage IV malignancy; status post cardiac arrest; and diagnosis of intracerebral hemorrhage requiring mechanical ventilation.\[99\].
- 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.
- Criteria for exclusion include inability to stand or walk for at least 10 minutes prior to admission; inability to shift weight in bed or assist with turning, inability of staff to access bariatric equipment such as an overhead trapeze, chair, or walker.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00999011
Start Date
May 1 2009
End Date
March 1 2013
Last Update
March 31 2022
Active Locations (1)
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1
Frances Payne Bolton School of Nursing Case Western Reserve University
Cleveland, Ohio, United States, 44106