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临床试验/NCT06409611
NCT06409611已完成不适用

Muscle Effects Of Neuromuscular Electrostimulation In Mechanically Ventilated Patients In An Icu

Universidade Federal do Rio de Janeiro6 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
6
主要终点
Pennation angle (degrees)

研究概览

简要总结

To prevent the development of ICUAW, both early mobilization and neuromuscular electrical stimulation (NMES) have been shown to prevent muscle atrophy in critically ill patients by preserving muscle mass. Furthermore, it is of great value that muscle assessment using kinesiological ultrasound becomes routine to monitor this patient's profile with regard to strength, muscle quality and muscle mass. Our objective is to evaluate the muscular changes promoted by NMES in patients under mechanical ventilation. This is a randomized clinical trial study, which will perform NMES sessions for at least 7 days in mechanically ventilated patients. They will also undergo ultrasound assessments of the quadriceps. Patients will be divided into a control group and an NMES group. In addition, general information recorded in the medical record will be collected, such as basic characteristics, laboratory tests and general assessments.

详细描述

This is a randomized clinical trial study, which will be carried out at the Hospital Universitário Pedro Ernesto between the months of May 2024 and November 2025, where patients admitted to the General CTI will undergo muscle assessments through ultrasound and a protocol of NMES over a period of 7 days. Participants will be randomized and allocated into 2 groups: Control and NMES. After randomization, general information recorded in the medical record will be collected, such as baseline characteristics, laboratory tests, general assessments, Sequential Organ Failure Assessment Score (SOFA), Chelsea Critical Care Physical Assessment Tool (CPAx) functional scale, edema classification, quality and type of contraction during each NMES session, days on pressure support ventilation (PSV) and pressure or volume assist-controlled ventilation (PCV or VCV), use of neuromuscular blocker, corticosteroids, vasoactive amine and the type and days of diet. Patients will undergo ultrasound evaluation of the pennation angle (AP) of the vastus lateralis, cross-sectional area (CSA) of the rectus femoris, thickness (ESP) of the quadriceps and echogenicity (ECHO) of the rectus femoris, within the first 24h post intubation, at 3 days and 7 days post intubation. Muscle assessment was carried out by professional physiotherapists trained and certified for this purpose. For the NMES group, NMES therapy will be performed for 1 hour, once a day and for 7 days. Using the following parameters: Biphasic and symmetrical rectangular pulse, with a frequency of 50Hz, pulse width of 500μs, ON time of 10 seconds, OFF time of 15 seconds, 3 seconds of rise time and 2 seconds of descent time. The intensity is increased to the point that there is complete muscle contraction, visible or palpable. The maximum intensity will be 120 mA.

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
Single (Outcomes Assessor)

盲法说明

olhar em artigos

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

  • Age ≥18 years;
  • On mechanical ventilation in the first 24 hours;
  • Provision of written, informed and/or agreed consent for a family member.

排除标准

  • Trauma to the lower limb;
  • History of neurological, neuromuscular or debilitating diseases;
  • Spinal cord injury;
  • Rhabdomyolysis;
  • Vascular insufficiency or amputation of the lower limb;
  • Previous immobility;
  • Musculoskeletal and skin conditions or situations that may interfere in conduct.

研究组 & 干预措施

neuromuscular electrical stimulation (NMES)

Experimental

For the NMES group, NMES therapy will be performed for 1 hour, once a day and for 10 days. Using the following parameters: Biphasic and symmetrical rectangular pulse, with a frequency of 50Hz, pulse width of 500μs, ON time of 10 seconds, OFF time of 15 seconds, 3 seconds of rise time and 2 seconds of descent time. The intensity is increased to the point that there is complete muscle contraction, visible or palpable. The maximum intensity will be 120 mA.

干预措施: neuromuscular electrical stimulation (Device)

Placebo

Active Comparator

This group will perform conventional physiotherapy according to institutional protocol. Rehabilitation was oriented towards achieving daily motor milestones (sitting on the edge of the bed, sitting in an armchair, getting up and walking) according to the CPAx scale. The same electrostimulation device will be installed, but it will not be turned on.

干预措施: neuromuscular electrical stimulation (Device)

结局指标

主要结局

Pennation angle (degrees)

时间窗: First, fifth and tenth days.

Pennation angle measured by ultrasound

次要结局

  • Cross-sectional area (cm2)(First, fifth and tenth days.)
  • Echogenicity (AU)(First, fifth and tenth days.)
  • Thickness (cm)(First, fifth and tenth days.)
  • Days free from mechanical ventilation(28-day interval.)
  • Extubation success rate (%)(28-day interval.)
  • ICU mortality rate (%).(28-day interval.)

研究者

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

Jose Roberto Lapa e Silva

Full Professor of Pneumology

Universidade Federal do Rio de Janeiro

研究点 (6)

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