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临床试验/NCT03814538
NCT03814538Unknown不适用

Assessment of the Incidence of Expiratory Flow Limitation in Patients Undergoing Thoracic Surgery

University of Parma1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Incidence of EFL

研究概览

简要总结

Background and rationale of the study: During general anesthesia, the residual functional capacity (FRC) is reduced. If the FRC is lower than the minimum volume necessary to maintain the airway opening (closing capacity, CC), a pulmonary parenchyma derecruitment leads to the phenomenon of expiratory flow limitation (EFL). In recent years, new methods are being studied to assess EFL. In the study by Marangoni E, et. al., has been shown how the sudden subtraction of 3 cmH2O to the value of the tele-expiratory positive pressure (PEEP test) is sufficient to establish the presence of the EFL.

The presence of EFL measured by this method seems to correlate, in abdominal surgery, with the development of post-operative pulmonary complications. In the area of anesthesia in thoracic surgery, neither the incidence nor the relevance of the EFL are known, so a study is needed that evaluates both.

The aim of the study is to determine the incidence of expiratory flow limitation in patients undergoing thoracic surgery and ventilated in bi and monopolmonary mode.

The protective ventilation is a mechanical ventilation with a current volume (TV) of 6-8 mL / kg among to the ideal body weight (IBW), PEEP of 3-5 cmH2O and a FiO2 <80%.

The aim of this study is to evaluate the incidence of EFL in patients undergoing thoracic surgery, planned by thoracoscopy and thoracotomy in election, and to correlate this parameter with the onset of postoperative pulmonary complications. The final aim will be to verify if it is possible to identify a better approach, through the personalization of mechanical ventilation during the surgery, to reduce mortality, morbidity and hospital stay after thoracic surgery.

详细描述

It's a prospective and observational study, with 100 patients that undergo thoracic surgery.

The respiratory rate will be set to maintain PaCO2 at values close to eucapnia.

Controlled pressure ventilation (Pinsp ≤ 35 cmH2O) will be used only if the maximum airway pressures are reached and exceeded with controlled ventilation.

The inspiratory mixture will consist of O2: Air and possibly the halogenated anesthetic.

At the end of the operation, the patients will be transferred to Intensive Care Unit for post-operative monitoring. During the transfer will be supported with mechanical ventilation manually performed by the Anesthesiologist.

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

  • age >18 years old
  • signed informed consent
  • elective thoracic surgery
  • planned thoracic surgery with thoracotomy and thoracosthomy

排除标准

  • Patient refusal
  • Pregnancy
  • Patients undergoing emergency or emergency surgery
  • Patients underwent cardiac and surgery
  • patients underwent thoracic surgery with median sthernotomy

结局指标

主要结局

Incidence of EFL

时间窗: From the induction of general anesthesia, until the end of the surgical procedure, up to 10 hours

Evaluate the incidence of the EFL in patients undergoing thoracic surgery

Incidence of postoperative pulmonary complications (PPC) related to EFL

时间窗: From immediately after surgery until hospital discharge, up to 26 weeks

Evaluate the relationship between the incidence of EFL and the onset of PPC in patients undergoing thoracic surgery

次要结局

  • Incidence of length of in-hospital stay(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Incidence of Intensive Care Unit admission and its duration(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Duration of mechanical ventilation(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Incidence of cardiovascular postoperative complications(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Incidence of neurological postoperative complications(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Incidence of surgical postoperative complications(From immediately after surgery until hospital discharge, up to 26 weeks)
  • Incidence of mortality(From immediately after surgery until hospital discharge, up to 26 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Giovanna Bignami

Professor

University of Parma

研究点 (1)

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