Diaphragm Kinetics Following Hepatic Resection, Comparison Between a Sarcopenic and Non-sarcopenic Cohort.
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Diaphragm kinetics
研究概览
简要总结
Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery. Liver surgery induces reactive pleural effusion in most patients, compromising post-operative pulmonary function.
Hypotheses:
- Both major hepatic resection and sarcopenia have a measurable impact on diaphragm function.
- Sarcopenia is associated with reduced preoperative diaphragm function, and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection.
Goals:
The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared to non-sarcopenic patients, and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared to non-sarcopenic patients.
Methods and analysis:
Trans-costal B-mode, M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in patients undergoing major hepatic resection starting one day prior to surgery and up to thirty days after surgery. In addition, rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia, and pulmonary function will be measured using a hand-held bedside spirometer. Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level (L3). Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery (SPPB). A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status. Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18- and 80 years old
- •Patients undergoing elective Major hepatic resection for the treatment of malignant disease.
- •Patients with all tumor Stages (TNM classification).
- •Only patients undergoing Major hepatic resection.
排除标准
- •American Anesthesiology Association (ASA)-classification IV or higher
- •Liver cirrhosis Child grade B or higher
- •End stage renal disease requiring dialysis
- •Severe heart disease New York Heart Association class IV
- •Pulmonary condition:
- •Chronic obstructive pulmonary disease (COPD)
- •History of pulmonary surgery
- •History of pulmonary embolism
- •Pleural effusion occupying more than 1/3 of the pleural space
- •Neurological disorders leading to paraparesis of the upper or lower limbs
- •Known muscular dystrophic disorders
结局指标
主要结局
Diaphragm kinetics
时间窗: Day 1
Comparing diaphragm and abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound. Diaphragm muscle kinetics will be evaluated using the following value. -Range of DIA (in cm) Mean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
Abdominal muscle kinetics
时间窗: Day 1
Primary outcome: Comparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound. Abdominal muscle kinetics will be evaluated using the following value. -Deformation velocity (in cm/second) Mean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)
次要结局
- Diaphragm kinetics(30 days)
- Abdominal muscle kinetics(30 days)
研究者
Gregory van der Kroft
Principal investigator. Drs.
RWTH Aachen University
