Effect of Randomization to Neuromuscular Blockade on Physical Functional Impairment and Recovery in ARDS

Brief Summary
The proposed work will determine the effect of neuromuscular blockade on physical function and recovery in patients with ARDS. The investigators will conduct a prospective ancillary study at five PETAL clinical centers that will evaluate the neuromuscular structure and function of ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) patients during and after critical illness, including in-person assessments at 6 months after hospital discharge. The investigators hypothesize that patients randomized to NMB will have an increase in ICU-acquired neuromuscular dysfunction during and after critical illness.
Brief Title
Effect of Randomization to Neuromuscular Blockade on Physical Functional Impairment and Recovery in ARDS
Detailed Description
The investigators will assess this dysfunction in different ways, appropriate for patients' stage of critical illness and anticipated recovery. During critical illness, the investigators will use nerve conduction studies (NCS) to assess nerve and muscle function, identifying presence of early neuromyopathy (primary outcome, Aim 1). Additional early assessments will include bedside ultrasound to determine muscle mass and echogenicity, indices of atrophy and loss of muscle architecture. Later in acute hospitalization as patients are able to participate in testing, the investigators will use hand grip dynamometry to assess muscle strength (primary outcome, Aim 2). Additional assessments at this time will be hand held dynamometry to determine proximal muscle strength, dual energy x-ray absorptiometry (DEXA) and repeat ultrasound to evaluate muscle mass, and short physical performance battery (SPPB) to assess activity. After hospital discharge-at 6 months after ARDS-the investigators will assess activity in-person using the SPPB (primary outcome, Aim 3). Additional post-hospital assessments include detailed evaluation of healthcare utilization, six minute walk testing (6MWT) to determine endurance, and repetition of previous assessments of muscle structure, function and strength to provide novel, detailed information of recovery process.

Each aim tests a distinct hypothesis of the effect of randomization to NMB on ICU-acquired neuromuscular dysfunction, investigating different time points and aspects of physical function, so aims are not interdependent. For example, it is plausible that the direct toxicity of NMB on muscle will lead to early evidence of neuromyopathy, manifest as reduced muscle depolarization amplitudes with nerve stimulation. But if NMB attenuates lung injury, strength may be improved by hospital discharge, despite early injury to muscle.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
2067443356
Completion Date
Completion Date Type
Estimated
Conditions
Acute Respiratory Distress Syndrome
Neuromyopathies
Eligibility Criteria
Inclusion Criteria:

* Patients must be enrolled in the PETAL Network's ROSE study
* Patients must have at least one complete leg

Exclusion Criteria:

* Complete spinal cord injury with deficits at level T1 or above
* Severe peripheral neuromuscular disease (specifically motor neuron disease (ALS) or acute Guillain-Barre Syndrome)
* Inability to obtain informed consent
Inclusion Criteria
Inclusion Criteria:

* Patients must be enrolled in the PETAL Network's ROSE study
* Patients must have at least one complete leg

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03038906
Org Class
Other
Org Full Name
University of Washington
Org Study Id
PRIMROSE
Overall Status
Unknown status
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Effect of Randomization to Neuromuscular Blockade on Physical Functional Impairment and Recovery in ARDS
Primary Outcomes
Outcome Description
The investigators are assessing neuromyopathy with electrophysiologic testing
Outcome Measure
Neuromyopathy
Outcome Time Frame
Through 6 months after hospital discharge
Outcome Description
The investigators are assessing muscle strength with handgrip and handheld dynamometry
Outcome Measure
Muscle Function and Strength
Outcome Time Frame
Through 6 months after hospital discharge
Outcome Description
The investigators are assessing physical recovery with the short physical performance battery
Outcome Measure
Physical Recovery and Healthcare Utilization
Outcome Time Frame
6 months post ARDS
Start Date
Status Verified Date
First Submit Date
First Submit QC Date
Study Population
Subjects enrolled in the PETAL Network's ROSE (Reevaluation of Systemic Early Neuromuscular Blockade) Study.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Aluko Hope
Investigator Email
ahope@montefiore.org
Investigator Phone
718-920-8750