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临床试验/NCT05412095
NCT05412095已完成不适用

Evaluation of the Prognostic Value of Preoperative Quadriceps and Respiratory Muscle Thickness by Ultrasound Measurement in Cardiac and Thoracic Surgery Patients: a Prospective Observational Study

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2022年5月31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
301
试验地点
1
主要终点
Occurrence of a cardiovascular complication

研究概览

简要总结

Cardiac and thoracic surgery are major procedures. In order to estimate the operative risk, many scores have been developed, including the Euroscore 2 in cardiac surgery. However, the Euroscore has limitations since it does not assess all the parameters that may influence postoperative complications, such as the patient's general condition or the status of his or her functional reserves.

However, it has been shown that the preoperative functional reserves have a significant impact on the patient's risk of developing postoperative complications following major surgery. In addition, there is a strong association between cardiac failure and a well-described decrease in peripheral muscle lean mass (sarcopenia) in patients older than 65 years.

Usually, a nutritional assessment is performed during the pre-anesthesia consultation. This assessment is based on clinical and biological criteria that are not totally predictive of the patient's functional reserve status.

Lean body mass (muscle) is a well-validated marker for the assessment of patients' functional reserves. However, the techniques used to date are complex and require radiation.

This study aims to use ultrasound of muscle groups (respiratory muscles - Quadriceps muscle - Diaphragm) to study the relationship between preoperative muscle mass and postoperative complications in patients over 65 years of age undergoing cardiac or thoracic surgery.

This is a prospective observational study to be conducted at the Dijon University Hospital by the cardiovascular anesthesia-intensive care department. A total of 300 patients will participate in this study, and we have planned to complete the project over a 2-year period. The participating patients (if they do not present any exclusion criteria and are not opposed to inclusion) will be included and undergo a muscle ultrasound in the cardiovascular surgery department or the thoracic and pulmonary surgery department the day before their intervention.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient 65 years or older
  • Patients who have not objected to their inclusion in the study
  • Any patient requiring elective cardiac surgery, with extracorporeal circulation extracorporeal circulation OR
  • Any patient requiring lung surgery with resection of at least one lobe

排除标准

  • pneumectomy
  • Person who is not affiliated to national health insurance
  • Person subject to a measure of legal protection (curatorship, guardianship)
  • Pregnant, parturient or breastfeeding women
  • Major unable to express consent
  • Persons with amputations of the proximal segment of a lower limb
  • Persons suffering from a pre-existing neuromuscular pathology, tetra or paraplegia
  • Person who must undergo emergency surgery

研究组 & 干预措施

Cardiology patient

Patient requiring cardiac surgery with bypass

干预措施: Ultrasound of the abdominal wall muscles (Other)

Cardiology patient

Patient requiring cardiac surgery with bypass

干预措施: Ultrasound quadricipital (Other)

Cardiology patient

Patient requiring cardiac surgery with bypass

干预措施: Ultrasound of the diaphragm (Other)

Cardiology patient

Patient requiring cardiac surgery with bypass

干预措施: Ultrasound of the inter-costal muscles (Other)

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

干预措施: Ultrasound of the abdominal wall muscles (Other)

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

干预措施: Ultrasound quadricipital (Other)

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

干预措施: Ultrasound of the diaphragm (Other)

Pneumology patient

Patient requiring lung surgery with resection of at least one lobe

干预措施: Ultrasound of the inter-costal muscles (Other)

结局指标

主要结局

Occurrence of a cardiovascular complication

时间窗: Within 30 days after surgery

Death

时间窗: Within 30 days after surgery

Onset of acute renal failure

时间窗: Within 30 days after surgery

Occurrence of an infectious complication

时间窗: Within 30 days after surgery

Occurrence of a respiratory complication

时间窗: Within 30 days after surgery

Occurrence of acute respiratory failure in cardiac surgery and occurrence of a severe extra-respiratory complication according to the european perioperative clinical outcome definition in pulmonary surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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