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.
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 interleukin (IL)-6 and IL-10 2. Physiological responses: peripheral oxygen saturation, heart rate, blood pressure, new dysrhythmias 3. Safety/Unsafe events including pain, fatigue, line or tube dislodgement, fall or near fall 2. Determine the associations between duration and level of activity/ETM achieved and outcomes: 1. occurrence of delirium 2. occurrence of ventilator associated pneumonia 3. occurrence of deep vein thrombosis or pulmonary emboli 4. occurrence of acquired pressure ulcer 5. muscle strength 6. number of days mechanically ventilated 7. discharge location (after ICU) 3. Describe strategies used in the ICU to initiate and implement activity with and without an ETM protocol 1. use of personnel such as registered nurses, physical therapists, respiratory therapist and nursing assistants 2. use of equipment such as a walker, lift device, belt or bed 3. perception of sufficient time and abilities 4. Describe patient factors that are associated with implementation of ETM 1. Potentially modifiable exemplars: sedation, site of vascular access, physician orders 2. Potentially nonmodifiable exemplars: weight, consciousness, hemodynamic instability, terminal condition This is a prospective, longitudinal, repeated measures study with a control period, run-in period and intervention period. Data will be collected during all three periods for comparison. During the control period, patients will receive standard care. Standard care in this institution does not include a program of progressive or early mobility but does include activities similar to the ETM protocol, implemented at the discretion of the staff. During the run-in period, subjects will receive a mix of standard care and the intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
ETM is 4 levels. Level 1, each receives repositioning from lateral to supine positions at even hours, totaling 60 minutes of activity/positioning over 24 hours. If tolerated, two periods of 20 minutes of supine position with a reverse trendelenberg position of 15-20 degrees will be used to promote orthostasis. Level 2 is turning every 2 hours, positioning in reverse trendelenberg at 15-25 degrees as tolerated, active resistance with ICU staff for 20 minutes daily for a total of 60-80 minutes of activity/positioning daily. At Level 3, 2 times 20 minutes of a sitting are added to active ROM and inbed turning (estimated 80-100 total minutes of activity daily). Sitting is in bed or with non-weightbearing assisted transfer to chair with backrest elevation at 75-90 degrees and legs in a dependent position. Level 3 interventions; minimal weight-bearing. Level 4, weight-bearing transfer to chair and ambulation are added to inbed turning.
Compare immediate molecular and physiological patient responses to activity with responses to an ETM protocol.
Time frame: 1, 2, 3, 7, days then weekly
A secondary aim is to identify strategies and conditions that promote or prevent ETM.
Time frame: 1, 3, 5, 7, days then weekly
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