Evaluation of Diaphragmatic Function and Quadriceps Muscle Thickness Using Ultrasonography in Critically Ill Mechanically Ventilated Patients Receiving High Protein Nutrition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on diaphragmatic muscle function in mechanically ventilated patients in ICU for 4 weeks.
研究概览
简要总结
Different Protein Doses' Effect on Diaphragmatic Function and Quadriceps Thickness
详细描述
Nutrition therapy is no longer a support method for critically ill patients but is considered an important treatment measure. Increasing the protein and energy available to patients in the intensive care unit (ICU) reduces infection and complications, increases ventilator-free days, increases long-term physical recovery, and lowers patient mortality Among critically ill patients, protein is the most important macronutrient because it promotes healing, improves immune function, and helps patients maintain their lean body mass. Growing evidence has shown that adequate protein intake may be more important than caloric intake in the body. In addition, reaching at least 80% of the prescribed protein intake rather than energy intake is related to improved survival rates in ICU patients.
Muscular atrophy is a common feature in patients with intensive care unit-acquired weakness (ICU-AW), and it can start in the early stages of critical illness (within hours of onset of the disease). Its development has been related to the acute inflammatory process and immobilization. Factors such as age, medications, comorbidities, nutrition, and nervous, and muscular damage before critical illness can contribute to the extent of atrophy and the muscular and functional recovery capacity.
It was believed that perhaps the respiratory muscles in humans were spared any loss of muscle protein during starvation because of their constant activity. In a necropsy study designed to assess the diaphragm in health and disease, it was found that alterations in body weight and muscularity profoundly affect the diaphragm muscle mass.
Mechanical ventilation (MV) is the most important life-sustaining measure for critically ill patients, Even if the MV is maintained for a short time, diaphragm fatigue may also occur owing to atrophy or decreased contractile function, which is known as ventilator-induced diaphragm dysfunction (VIDD). Pathophysiological changes of VIDD include muscle atrophy, structural damage, and fiber-type transformation and remodeling.VIDD is the main factor contributing to difficult weaning from long-term MV in critically ill patients. Prolonging the time of MV is associated with an increased risk of complications, long-term dysfunction, and death.
Muscles of the lower limb are more prone to early atrophy as they are weight-bearing compared to the muscles of the upper limb as shown in previous studies. The authors showed that the size of the flexor compartment of the elbow did not show any change in the first 10 days of admission, whereas the size of the anterior compartment muscles of the lower limb showed a greater decrease in thickness within the first 5 days. Thus, these muscles make a good choice for muscle mass assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Acceptance of the first-degree relatives.
- •Critically ill patients: patients with a life-threatening condition that requires pharmacological and/or mechanical support of vital organ functions without which death would be imminent.
- •Patients anticipated to be mechanically ventilated for ≥ 48 hours
- •Patients who expected ICU stay ≥ 4 weeks
- •Patients aged between 18 - 60 years of both sexes.
- •Patient nutrition risk screening (NRS 2002) score ≥ 3
- •Patient BMI less than 35
- •No contraindication to early enteral nutrition.
排除标准
- •• Patient with Trauma to both lower extremities, diaphragm disease (trauma, immobilization....), myopathy, and moderate to severe hepatic insufficiency.
- •Patient receiving steroids.
- •Patient on renal replacement therapy.
- •Prior MV before admission.
- •Pregnant.
- •Patient with neuromuscular disease, spinal cord injury, thoracic deformity, and respiratory restriction.
- •Patients require muscle paralysis on MV.
- •Patients require high dose inotrope or vasopressor.
结局指标
主要结局
To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on diaphragmatic muscle function in mechanically ventilated patients in ICU for 4 weeks.
时间窗: from time of ICU admission on day 0,then on days 3, 5, 7, then weekly till the fourth week.
assessment of the effect of different protein doses per day on diaphragmatic muscle function in mechanically ventilated patients using ultrasound, the following data will be assessed: 1. Diaphragm thickness (mm) on days (0, 3, 5, and 7 from ICU admission then weekly till the fourth week ). 2. Diaphragm thickening fraction on the day (0, 3, 5, 7 then weekly till the fourth week ) 3. Diaphragm excursion during the weaning trial during spontaneous breathing trial (SBT).
次要结局
- To assess the effect of different protein doses (1.2 gm/kg per day versus 2 gm/kg per day ) on Quadriceps muscle thickness(mm) in mechanically ventilated patients in ICU for 4 weeks.(from time of ICU admission on day 0, then on days 3, 5, 7, then weekly till the fourth week)
研究者
Naglaa Fathy Abdelhaleem Abdelhaleem
Lecturer of anesthesia and ICU
Zagazig University