Muscle Ultrasound Signifies Condition Upgrade Leading Approach to Recovery



Status:Completed
Conditions:Hospital, Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:11/10/2017
Start Date:November 2012
End Date:May 3, 2017

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Examination of serial muscle ultrasounds and muscle sampling within the population of ICU
patients who require mechanical ventilation for acute respiratory failure, will lead to the
ability of investigators to link specific baseline comorbidities, drugs, or fluid
administrations, to the onset and duration of architectural changes within muscle and
correlate ultimately with muscle function. With this study, we will be better able to
understand the relationships between the pattern of resolution of the muscle architectural
abnormalities within the context of multiple other clinical abnormalities and therapies
present and rendered to ICU patients.

Acute respiratory failure (ARF) is an extremely variable and heterogeneous syndrome that can
be defined as an acute cardiopulmonary dysfunction requiring emergent artificial ventilation
support. For patients with ARF, the mortality rate is higher than the general ICU mortality,
with estimates ranging from 15-40% depending on the subgroups evaluated. In the largest, most
recent report on ARF, the in-ICU mortality was 31% and the overall in-hospital mortality rate
was 37%. Muscle weakness is an independent risk factor for mortality from ARF and contributes
to long-term reductions in physical function in survivors. Muscle ultrasounds are
non-invasive, quick and reproducible. They provide the opportunity of ICU staff to create a
patient-specific exercise prescription based on both functional assessments and importantly
the degree of muscle architecture abnormality detected by ultrasound. Serial examination of
muscle ultrasound images obtained in mechanically ventilated acute respiratory failure
patients will allow for better understanding of the time course of specific muscles'
architectural abnormalities and the resolution of such abnormalities within hospital
survivors. With this study, we will be better able to understand the relationships between
the pattern of resolution of the muscle architectural abnormalities within the context of
multiple other clinical abnormalities and therapies present and rendered to ICU patients.
Muscle sampling used in conjunction with ultrasound in patients with ARF will allow for
further characterization of the extent of and mechanisms underlying ARF induced muscle
dysfunction in these patients. Furthermore, ultrasound guided muscle sampling allows this
procedure to be done in a more efficient and effective manner. Study participants will
consist of 30 patients with ARF admitted to the Intensive Care Units of Wake Forest
University Baptist Medical Center. Muscle ultrasounds will occur at study enrollment and
weekly thereafter, and will also include one imaging session as close to hospital discharge
as possible. Muscle sampling will occur within 5 days of consent and approximately 2 months
later. Handgrip strength, dynamometer, and physical performance tests will also be
administered at ICU & hospital discharge and at 2 months post enrollment. The primary outcome
will be to investigate the possibility of a relationship between the ultrasound data, muscle
sample data, and functional measurements (length of stay, grip strength, SPPB, dynamometer,
MRC, simultaneously accounting for severity of illness [APACHE III]).

Inclusion Criteria:

- Age > 18 years

- Mechanically ventilated via an endotracheal tube or mask

- New diagnosis of Acute Lung Injury or Sepsis

Exclusion Criteria:

- Upon Principle Investigator discretion, patient not suitable for study

- Moribund

- Other Research Study without co-enrollment permissions

- Pregnancy

- Primary neuropathies

- Amputees

- Inability to walk without assistance prior to diagnosis (use of cane or walker not
exclusion)

- Preadmission immunocompromised state (HIV, >20mg prednisone/day, other
immunosuppressive therapy)

- BMI >45 (difficulty obtaining biopsy)

- Underlying neuromuscular disease

- Acute stroke

- Hip fracture, unstable C spine, or pathological fracture

- Current hospitalization or transferring hospital stay >80 hours

- CPR previous to consent without signs of full neurologic recovery

- Previous hospitalization within past 30 days

- Cognitive impairment prior to ICU illness

- Re-admission to ICU within current admission

- Cancer therapy within the last 12 months

- Full dose anticoagulation therapy

- Known platelet count <100,000

- Known INR >1.5

- Known aPTT >1.5 upper limit of normal

- Patient on antiplatelet therapy (daily aspirin therapy is acceptable)
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Principal Investigator: Peter E Morris, MD
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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from
Winston-Salem, NC
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