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临床试验/NCT03038906
NCT03038906Unknown不适用

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

University of Washington1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
290
试验地点
1
主要终点
Neuromyopathy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Neuromyopathy

时间窗: Through 6 months after hospital discharge

The investigators are assessing neuromyopathy with electrophysiologic testing

Physical Recovery and Healthcare Utilization

时间窗: 6 months post ARDS

The investigators are assessing physical recovery with the short physical performance battery

Muscle Function and Strength

时间窗: Through 6 months after hospital discharge

The investigators are assessing muscle strength with handgrip and handheld dynamometry

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Hough

Associate Professor of Medicine

University of Washington

研究点 (1)

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