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临床试验/NCT01868347
NCT01868347Unknown3 期

The Obese Patient in the Urologic Robotic Surgery: the Role of a Preemptive Ventilator Strategy and Partitioning to Contrast Pneumoperitoneum and Trendelenburg Position

University of Turin, Italy2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
40
试验地点
2
主要终点
evaluation of arterial oxygenation

研究概览

简要总结

Analysis of the specific elastance during general anesthesia in patients treated with RARP (robotic assisted radical prostatectomy), to evaluate the efficacy of the preemptive strategy, involving recruitment maneuver and setting of 10 cmH2O PEEP before induction of pneumoperitoneum and trendelenburg position.

详细描述

RARP (robotic assisted radical prostatectomy) requires the induction of pneumoperitoneum and the trendelenburg position, causing increase in the intra-abdominal pressure and cephalic shift of the diaphragm, with consequent airway closure and collapse of the dependent regions of the lung.

Obese subjects present an increased risk of respiratory complications, caused not only by the surgical procedure itself, but also by the respiratory mechanics changes associated with the body mass. In obese patients we can observe higher values of lung and chest wall elastance, with reduction in ventilation-perfusion ratio.

The partitioning between lung and chest wall elastance can improve ventilatory setting and mechanics parameters of ventilation.

In every patient we will place, after anesthesia induction, a catheter to get esophageal and gastric pressure that represent pleural and abdominal pressure.

Ventilation will be conducted with a tidal volume of 8-10 ml/kg (IBW) and a respiratory rate adequate to maintain a physiological level of Pa CO2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • BMI >= 30
  • Robotic-assisted laparoscopic prostatectomy

排除标准

  • Chronic cardiac or pulmonary diseases

结局指标

主要结局

evaluation of arterial oxygenation

时间窗: at 6 hours (average duration of surgery procedure)

次要结局

  • evaluation of specific static elastance of the lung(at 6 hours (average duration of surgery procedure))
  • evaluation of difference between arterial end-tidal partial pressure of carbon dioxide(at 6 hours (average duration of surgery procedure))

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

PierPaolo Terragni

MD

University of Turin, Italy

研究点 (2)

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