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临床试验/NCT03177564
NCT03177564Unknown不适用

A Randomized Controlled Trial to Assess the Feasiblity of a Driving Pressure Limited Ventilation vs.Standard Strategy During Video-assisted Thoracoscopic Lobectomy

The Affiliated Hospital of Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年6月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
The incidence of postoperative pulmonary complications

研究概览

简要总结

This study aims to investigate the feasibility of a driving pressure limited mechanical ventilation strategy compared to a conventional strategy in patients undergoing one-lung ventilation during Video-assisted thoracoscopic lobectomy.

详细描述

• More recently, the so-called lung-protective intraoperative ventilation strategies have been advocated to prevent lung injury. Such strategies aim at minimizing lung hyperinflation as well as cycling collapse and reopening of lung units, through the use of low tidal volumes (VTs) and positive end-expiratory pressure (PEEP). However, despite huge improvements in surgical and anesthesia techniques and management. It is surprising that, so far, mortality and pulmonary complication rates were not reduced over time .Recently, several investigations suggest an association between high driving pressure (the difference between the plateau pressure and the level of PEEP) and outcome for patients with acute respiratory distress syndrome. It is uncertain whether a similar association exists for high driving pressure during surgery and the occurrence of postoperative pulmonary complications. In this issue, Ary S Neto and colleagues report an individual patient data meta-analysis further investigating the risk of mechanical ventilation in healthy individuals during general anesthesia .After both a multivariate and mediation analysis, the driving pressure, but not the tidal volume or the positive end-expiratory pressure applied, seemed to be the only parameter that was associated with the development of postoperative pulmonary complications. This randomized controlled trial is aims to prove that driving pressure limited ventilation is superior in preventing postoperative pulmonary complications to existing protective ventilation.

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
Double (Participant, Outcomes Assessor)

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

  • Adults greater than or equal to 18 years
  • ARISCAT(Assess Respiratory Risk in Surgical Patients in Catalonia)≥26 points
  • Patients undergoing video-assisted thoracoscopic lobectomy

排除标准

  • The American Society of Anesthesiologists (ASA) Physical Status classification greater than or equal to 4
  • Emergency surgery
  • Pulmonary hypertension
  • Forced vital capacity or forced expiratory volume in 1 sec < 70% of the predicted values
  • Coagulation disorder
  • Pulmonary or extrapulmonary infections
  • History of treatment with steroid in 3 months before surgery
  • History of recurrent pneumothorax
  • History of lung resection surgery
  • History of mechanical ventilation in 2 weeks
  • Body Mass Index[≥35 kg/m2 ]
  • Patient who is contraindicated with application of positive end expiratory pressure

结局指标

主要结局

The incidence of postoperative pulmonary complications

时间窗: within the first 3 days after surgery

Patient is regarded to have postoperative pulmonary complication when 4 or more positive variables exists according to Melbourne Group Scale.

次要结局

  • Partial pressure of oxygen in arterial blood(15 min after induction, 20 and 60 min after start of one-lung ventilation, 15 min after restart of two-lung ventilation, 1 hour after the end of surgery)
  • respiratory compliance(during surgery)
  • TNF-α(the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation)
  • IL-8(the start of one-lung ventilation, 1 hour of one-lung ventilation and the end of one-lung ventilation)
  • ICU mortality(Patients will be followed during the period of hospital stay, an expected average of 28 days)
  • In-hospital mortality(Patients will be followed during the period of hospital stay, an expected average of 28 days)
  • 28-day survival(From day 0 to day 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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