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临床试验/NCT02817893
NCT02817893Unknown不适用

Comparison of Respiratory Variations of the Pulse Oximetry Plethysmographic Raw Signal and Pulse Pressure During Abdominal Surgery (PLETHYSMO)

Hospices Civils de Lyon0 个研究点目标入组 20 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
∆PP: pulse pressure variation

研究概览

简要总结

The waveform plethysmographic signal can be used to establish an index for predicting fluid responsiveness (∆POP: respiratory variation of the plethysmographic waveform of pulse oximetry). This index was validated in some studies and because of its non-invasiveness it seems very interesting in anesthesia.

However, in a previous study the investigators evaluated the correlation between the results provided by this index (∆POP) and those of the reference index (∆PP: pulse pressure variation), and the obtained results were significantly lower than what had been previously described. In this study, the index was calculated from a recording of a filtered signal. This unavoidable application of a filter on anesthesia monitors could contribute to the discrepancy between the ∆POP and the ∆PP.

The realization of a new study, comparing ∆PP and ∆POP obtained from an unfiltered plethysmographic signal, should answer the ∆POP ability to be used in place of ∆PP.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospital patient in general surgery and digestive department
  • Digestive sus mesocolic surgery with direct abdominal approach justifying a semi-invasive hemodynamic monitoring by arterial catheterization (liver, pancreatic, gastric and duodenal surgery)
  • Surgical approach by laparotomy
  • Patient under general anesthesia with mechanical ventilation
  • Agreeing to participate in the study after receiving information note

排除标准

  • Known left systolic ventricular and/or diastolic failure
  • Arrhythmias
  • Surgery performed with thoracic approach
  • Surgery by laparoscopy
  • Emergency surgery
  • Hypersensitivity or allergic to any of the product used for usual anesthesia, hypersensitivity to soya or egg lecithin
  • Personal or familial history of malignant hyperthermia
  • Severe kidney impairment (creatinin clearance <30ml/min)
  • Patients who participated in the previous month to another study protocol
  • Pregnant women or nursing
  • Under-age

结局指标

主要结局

∆PP: pulse pressure variation

时间窗: Day 0

reference index measured during abdominal surgery

∆POP: respiratory variation of the plethysmographic waveform of pulse oximetry

时间窗: Day 0

noninvasive index obtained from plethysmographic raw signal measured during abdominal 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

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