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临床试验/NCT03914976
NCT03914976已完成不适用

Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
post-operative complications

研究概览

简要总结

Intra-operative hemodynamic management in high-risk surgery is a priority for the anesthesiologist. The current strategy is based on the continuous measurement of cardiac output and its maximization by vascular filling has many limitations: invasiveness, measurement difficulties, impaired performance, imperative surgical restriction of filling, lack of evaluation of flow rate and metabolic needs. Biomarkers may be able to detect early an inadequacy between cardiac output and tissue oxygen requirements, venous saturation with oxygen (ScvO2) and arteriovenous difference in partial pressure of carbon dioxide (ΔPCO2) as well as the appearance of cellular hypoxia (lactate and arteriovenous difference in partial pressure of carbon dioxide/arteriovenous difference in oxygen) (ΔPCO2) / DAVO2). Moreover, the medical literature remains poor on the evaluation of these markers in per-operative context all the more for ΔPCO2 and ΔPCO2 / DAVO2. It seems interesting to evaluate the potential of these tools, in patients with major surgery and at high risk (major hepatectomy, oesophagectomy and duodeno-pancreatectomy), to predict the risk of postoperative complications, especially since surgery involves a restrictive vascular filling strategy that may be potentially deleterious to the patient.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Major patient
  • Patient eligible for a high risk scheduled gastrointestinal surgery from:
  • Esophagectomy
  • Major hepatectomy (≥ 3 segments)
  • Cephalic duodeno-pancreatectomy Patient with an arterial catheter and a central venous line in superior vena cava.
  • Patient hospitalized post-operatively in intensive care unit as agreed in consultation with preoperative anesthesia.

排除标准

  • Pregnant or lactating patients
  • Patient with an unstable acute condition at the time of surgery (acute heart, respiratory or renal failure, severe sepsis or septic shock, hemorrhagic shock)
  • Patient opposing his participation in the study
  • Patient protected by law (guardianship)
  • Patient deprived of liberty
  • Patient with a contraindication to the establishment of a central venous route in superior vena cava territory or a radial or femoral arterial catheter

结局指标

主要结局

post-operative complications

时间窗: 28 days after surgery

post-operative complications of grade III or greater according to Clavien-Dindo classification

mean intraoperative PCO2 values

时间窗: during surgery

PCO2 values will be collected every 2 hours during surgery

mean postoperative PCO2 values

时间窗: within 24 hours after 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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