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临床试验/NCT06368908
NCT06368908Unknown不适用

Transcutaneous Functional Magnetic Muscle Stimulation in Critically Ill

General and Teaching Hospital Celje2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
Measurement of Thickness of Thigh Muscles

研究概览

简要总结

ICU-Acquired weakness (ICU-AW) is a significant complication of critical illness. ICU-AW is common in patients with sepsis, systemic inflammatory response, and mechanically ventilated. It is estimated that around 50% of patients recovering from the primary illness remain in intensive care with characteristic muscle weakness. This leads to dependence on mechanical ventilation, prolonging costly intensive care hospitalization. The myopathy causes persistent functional impairment, endangering patients long after hospital discharge.

Magnetic stimulation prevents inactivation atrophy of skeletal muscles, as demonstrated in the mobilized limb of rats. Transcutaneous magnetic stimulation of the quadriceps via the femoral nerve is a safe and painless method even when applied to humans.

In patients with chronic obstructive pulmonary disease (COPD), quadriceps magnetic stimulation increased spontaneous contraction force compared to the control group and improved quality of life. Patients with COPD tolerate quadriceps magnetic stimulation well, as it does not affect oxidative stress in muscles but does increase the size of slow-twitch muscle fibers.

In intensive care medicine, magnetic stimulation has been primarily used for diagnostic purposes in assessing diaphragm function, peripheral muscle strength assessment, and transcranial electrical stimulation as a diagnostic tool and therapeutic stimulation of brain cells. With the development of modern transcutaneous magnetic stimulators, the possibility arises for their use in intensive care medicine for therapeutic purposes such as preventing critical illness myopathy.

To date, no research has been conducted on the use and effectiveness of magnetic stimulation of peripheral muscles in critically ill individuals.

The aim of the study is to investigate the effect of Functional Muscle Magnetic Stimulation (FMS) on the development of ICU-AW.

详细描述

  1. Introduction

ICU-Acquired weakness (ICU-AW) is a significant complication of critical illness. ICU-AW is common in patients with sepsis, systemic inflammatory response, and mechanically ventilated. It is estimated that around 50% of patients recovering from the primary illness remain in intensive care with characteristic muscle weakness. This leads to dependence on mechanical ventilation, prolonging costly intensive care hospitalization. The resulting myopathy causes persistent functional impairment, endangering patients long after hospital discharge.

1.1 Pathophysiological basis of development of Critical illness myopathy The pathophysiological mechanisms of ICU-AW are poorly understood, leading to the absence of specifically targeted treatments for its prevention. In most patients, skeletal muscle atrophy is observed, particularly the loss of fast-twitch muscle fibers (type II) and decreased levels of myosin heavy chains (MyHC). The loss of MyHC is a consequence of disrupted balance between its synthesis and degradation. The most significant contributors to the development of ICU-AW include systemic inflammation, sepsis, immobilization, sedation, hyperglycemia, exposure to neuromuscular blocking agents and corticosteroids, resulting in decreased muscle mass and strength. The principal intracellular system for protein degradation in skeletal muscles is the ubiquitin-proteasome system, which also regulates MyHC degradation.

1.2 Physiotherapy and Transcutaneous Electrical Muscle Stimulation Therapeutic activity in the intensive care unit often begins with passive mobilization, especially in inactive and unconscious patients. In the treatment of critically ill patients is aimed to reduce sedation, providing appropriate analgesia, thus promoting faster awakening and cooperation, and encouraging active movement even in patients on mechanical ventilation.

For muscle strengthening and reducing atrophy, physiotherapy is often combined with peripheral transcutaneous electrical stimulation of skeletal muscles. With electrical stimulation muscle strength can be increase in non-critically ill patients by using stimulation protocols that do not induce muscle fatigue.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • consecutive critically ill patients, already after 2 to 3 days of treatment in the ICU, whose treatment is expected to require at least 10 days in the intensive care unit.

排除标准

  • Patients under 18 years of age
  • Patients with implanted electrical devices affected by magnetic fields
  • Patients with expected survival of less than 5 days
  • Pregnant women
  • Patients with bone and tissue injuries in the legs where standard physiotherapy cannot be performed
  • Patients receiving high-dose corticosteroids (equivalent to >300 mg hydrocortisone per day)
  • Patients receiving muscle relaxants
  • Patients whose relatives/caregivers do not provide written consent for participation in the study
  • Patients with extreme obesity (BMI over 35 kg/m2) or cachexia (BMI less than 20 kg/m2 or loss of 5% Body weight over 12 months):
  • Patients with brain death
  • Patients who do not consent to participate in the study

结局指标

主要结局

Measurement of Thickness of Thigh Muscles

时间窗: 0 day, 3-5 days, 9-12 days

Measurement of Thickness of Thigh Muscles by Ultrasound Thickness and cross-section of the muscle, muscle structure, assessment of subcutaneous edema will be evaluated using ultrasound examination with a linear probe 8-12MHz (UZ apparatus Vivid 70, GE Health care, USA). Ultrasound apparatus settings (frequency 12 Hz, Gain: 55 dB, Dynamic range: 75) will be kept constant for all patients, with depth adjusted only in the case of larger muscles. Measurements will be performed in transverse and sagittal muscle sections without and with compression of the ultrasound probe.

次要结局

  • Measurement of Thigh Circumference(0 day, 3-5 days, 9-12 days)
  • Body composition measurement by bioimpedance- Extracellular water(0 day, 3-5 days, 9-12 days)
  • Body composition measurement by bioimpedance- Intracellular water(0 day, 3-5 days, 9-12 days)
  • Body composition measurement by bioimpedance- skeletal muscle mass(0 day, 3-5 days, 9-12 days)
  • Assessment of Muscle Strength and Communication Ability(at admission and at the end of study (9-12day))

研究者

发起方
General and Teaching Hospital Celje
申办方类型
Other
责任方
Sponsor

研究点 (2)

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