Is Neuromuscular Electrical Stimulator Treatment in Sepsis/ Septic Shock Patients Protective in the Development of Intensive Care Unit Acquired Muscle Weakness (ICU-AW)?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Effects of NMES treatment on ICU-AW development, scoring systems.
研究概览
简要总结
Background: Sarcopenia (muscle weakness) characterized by a decrease in muscle mass, strength and performance is a condition that increases with old age. Sarcopenia can be seen in 5-13% of patients hospitalized in ICU where various treatment methods are used to prevent this weakness, the rate increases in patients with sepsis/ septic shock. Muscle treatment methods are used to prevent sarcopenia in similar patients hospitalized in ICU. It is predicted that "neuromuscular electrical stimulator-NMES" treatment may increase muscle mass and strength in patients who's can not be exercised actively. In this study, the contribution of NMES treatment to prevent the development of muscle weakness in patients with a diagnosis of sepsis/ septic shock followed in intensive care units (ICU) was evaluated.
详细描述
Background: Sarcopenia (muscle weakness) characterized by a decrease in muscle mass, strength and performance is a condition that increases with old age. Sarcopenia can be seen in 5-13% of patients hospitalized in ICU where various treatment methods are used to prevent this weakness, the rate increases in patients with sepsis/ septic shock. Muscle treatment methods are used to prevent sarcopenia in similar patients hospitalized in ICU. It is predicted that "neuromuscular electrical stimulator-NMES" treatment may increase muscle mass and strength in patients who's can not be exercised actively. In this study, the contribution of NMES treatment to prevent the development of muscle weakness in patients with a diagnosis of sepsis/ septic shock followed in intensive care units (ICU) was evaluated.
Patients and methods: In our single-center, prospective clinical study, 80 patients with a diagnosis of sepsis/ septic shock who were hospitalized in ICU were included. The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed. The day when our patients were diagnosed with sepsis was recorded as the first day of the study. Anthropometric and ultrasonographic measurements of bilateral biceps brachii and bilateral rectus femoris muscles were recorded on the following days i.e. 3, 7, 14, 21, and 28. Sarcopenia was defined by anthropometric and ultrasonographic measurement, and all patient outcome data were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being in the Intensive Care Unit
- •Over the age of 18
- •Diagnosed with sepsis/ septic shock
排除标准
- •Under the age of 18
- •Pregnancy
- •Having a cardiac pacemaker
- •Amputated lower limbs
- •Having severe venous insufficiency or major injuries to their lower extremities
- •Having neuromuscular disease
- •Malignancy
研究组 & 干预措施
NMES GROUP
NMES TREATMENT AND PHYSICAL TREATMENT
干预措施: NMES GROUP (Device)
CONTROL GROUP
JUST PHYSICAL TREATMENT
干预措施: NMES GROUP (Device)
结局指标
主要结局
Effects of NMES treatment on ICU-AW development, scoring systems.
时间窗: 28 days
When the follow-up was completed, duration of the ICU stay, intubated and/ or extubated days.
weight
时间窗: first day and last day (end of the 28th day)
We calculated the body weight of our patients by indirectly using the method of calculating body weight in bedridden patients. Age (Year) 6-18 Male : (Knee length (cm) x 0.68) + (Arm circumference (cm)x 2.64) -50.08 Female : (Knee (cm) x 0.77) + (Arm (cm) x 2.47) - 50.16 19-59 Male : (Knee (cm) x 1.19) + (Arm (cm) x 3.21) -86.82 Female : (Knee (cm) x 1.01) + (Arm (cm) x 2.81) - 66.04 60-80 Male : (Knee (cm) x 1.10) + (Arm (cm) x 3.07) -75.81 Female : (Knee (cm) x 1.09) + (Arm circumference(cm) x 2.68) - 65.51
Effects of NMES treatment on ICU-AW development, anthropometric measurement,
时间窗: 28 DAYS
The measurements of the patients were recorded as anthropometric (arm circumference and thigh circumference) on the 1st, 3rd, 7th, 14th, 21st and 28th days. Arm circumference(centimeter) measurement was measured from the thickest part of the biceps muscle(centimeter) when the elbow was flexed and thigh circumference (centimeter) was measured anthropometrically with a tape measure (centimeter), 15 centimeter above the patella with the leg in extension.
Effects of NMES treatment on ICU-AW development, ultrasonographic measurement
时间窗: on the 1st, 3rd, 7th, 14th, 21st and 28th days
Using an ultrasound imaging device, the thickness of biceps brachii (cm\^2) and rectus femoris muscles (cm\^2) were measured ultrasonographically (at the same points of anthropometric measurements) with the linear probe.
height
时间窗: first day and last day ( end of the 28th day)
The height of the patients was calculated by measuring the knee height from many alternative height measurement methods. The measurement includes the length from the base of the foot to the anterior surface of the thigh while the lower extremity is flexed and is easily taken Chumlea et al. The equation created by the Chumlea method, known as the Chumlea method, is the most accurate equation used to estimate standing height from knee height. This method has been cross-validated for use in ICU patients. The original estimated equations are given. White Male Estimated height (cm) = (knee height (cm) × 1.88) + 71.85 White Female Estimated height (cm) = (knee height (cm) × 1.87) - (0.06 × age (y)) + 70.25
Effects of NMES treatment on ICU-AW development, nutrition.
时间窗: 28 days
The diet of the patients were standardized by the dietitian.
Effects of NMES treatment on ICU-AW development, scoring systems.
时间窗: on the 1st, 3rd, 7th, 14th, 21st and 28th days
The muscle strength of the patients were evaluated according to the Medical Research Council (MRC) scoring.
Effects of NMES treatment on ICU-AW development, scoring systems.
时间窗: first day
On the first day of the study, qSOFA (quick Sequential Organ Failure Assessment) score scoring systems were calculated for each patients.
次要结局
未报告次要终点
研究者
GUNES COMBA CEBECI
RESIDENT
Ondokuz Mayıs University