Early Waking, ICU Acquired Weakness, Trauma
Conditions
Brief summary
traumatic brain injury (TBI) is a major public health concern worldwide. Patients with moderate-severe TBI have high rates of disability at the acute phase and frequently require protracted rehabilitation with prolonged periods of recovery. Recently, it has been found that the use of progressive early mobilization (EM) protocols for critical trauma patients may minimize the functional declines during intensive care unit (ICU) stays. However, prior early mobilization studies have found that the survivors of moderate-severe TBI often experience a greater incidence of neurological injuries with other organ injury than other critical care patients. No randomized controlled trials thus far have utilized measure the influence or effect of early progressive EM protocols on the functional recovery of moderate-severe TBI patients.
Detailed description
Objective: The goals of this proposed research study are (1) to investigate the feasibility of using a structured progressive EM protocol for patients with moderate-severe TBI in a trauma ICU and (2) The goal is to investigate and compare the intervention effects of a progressive EM protocol (aimed at bringing patients at least to the mobility level-3 of sitting on the edge of bed) in an ICU on short-term and long-term functional abilities in patients with moderate-severe TBI.
Interventions
BEHAVIORALEarly progressive mobilization
The goal will be to achieve a mobilization level of at least Level III (sitting on the edge of bed) during the ICU stay (within 7 days).
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Expected to stay for at least 72 hours in the ICU, * \>20 years of age with living independently before the onset of critical illness * relatively stable vital signs with a Glasgow Coma Scale (GCS) score of ≥6 * relatively stable respiratory status (SpO2 \>92%, high mechanical ventilator setting: FiO2 ≤60%, and positive end-expiratory pressure ≤10 cmH2O) * stable cardiovascular system (resting heart rate ≤130 bpm or no use of high-dose vasopressor of more than 0.2 μg kg-1 min-1)
Exclusion criteria
* predicted mortality within the next 24 hours * palliative care * consistent increase of intracranial pressure (\>20 mmHg) * pregnancy * uncontrolled seizure * active bleeding * ruptured or leaking aortic aneurysm * development of acute myocardial infarction during ICU stay * rapid development of degenerative neuromuscular diseases * contraindication for early walking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total score-change of the Perme ICU Mobility Score | at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset | The Perme ICU Mobility Score ranges from 0 to 32 points and is obtained by summing the score of 15 items, each one scored from 2 to 3 points. This score reflects the patient's mobility status in specific circumstances. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the achievement level of Modified Trauma ICU Mobility Scale | at baseline; at the time of ICU discharge; the time of hospital discharge | the achievement of Modified Trauma ICU Mobility Scale, Level 0-10 |
| the days of achievement of the walking motor milestone | up to 3 months | walking on a level surface for ≥50 meters with or without an assistive device |
| the values tested by in body s10 about lean body mass parameters | at baseline; at the time of ICU discharge; the time of hospital discharge/ an average of 30 days; | including phase angle, skeletal muscle mass, body fat mass, total body water etc. |
| The total score-change of the motor domain of the Functional Independence Measure (FIM-motor) | at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset | the FIM-motor consist of self-care tasks (eating, grooming, bathing, upper-body dressing, lower-body dressing, and using the toilet), sphincter control (bladder and bowel management), transfers (from bed or a chair to the toilet, bath, or shower), and locomotion ability (walking or wheelchair mobility, and stair climbing) |
| the hospital length of stay | up to 3 months | the hospital length of stay |
| the days of ventilator used | up to 3 months | the days of ventilator used |
| the discharge disposition after hospital discharge | up to 3 months | where a patient is being discharged - i.e. home, home with home care, skilled nursing facility, or rehab center. |
| the length of stay in the ICU | up to 3 months | the length of stay in the ICU |
Countries
Taiwan
Outcome results
None listed