Prospective, Randomized Study of the Effects of Pressure-controlled vs. Volume-controlled Ventilation During One Lung Ventilation on Lung Injury After Thoracotomy
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Determine changes in the serum levels of cytokines
研究概览
简要总结
Compared with the information available in sepsis and trauma-associated ARDS, less is known about the cause and pattern of lung injury after thoracic surgery. Definition of lung injury in this context is difficult. Most now use the joint North American-European consensus conference definitions, but these are based only on gas exchange and radiology criteria. While gas exchange measures are reliable, thoracotomy inevitably causes radiological change and the interpretation of plain chest films becomes subjective. Definitions based on permeability and inflammatory changes would improve diagnosis, but are not routinely available in most units.
Pressure-controlled volume (PCV) may be useful to improve gas exchange and alveolar recruitment with associated lower airway pressures and shunt fraction during one-lung ventilation (OLV).
However, a recent prospective randomized study of the effects of PCV during OLV did not lead to improved oxygenation during OLV compared with VCV, but PCV did lead to lower peak airway pressures. To date, there are no reports of the effects of PCV versus VCV during OLV on the acute lung injury (ALI) after thoracotomy.
详细描述
Project Objectives:
We hypothesize that the use of PCV during OLV for thoracic surgery may improve the anti-inflammatory immunoregulation than VCV. It may attenuate the increases in proinflammatory cytokines, including interleukins (IL-8, IL-1, and IL-6) and TNF-α, and prevent suppression of the anti-inflammatory cytokine (IL-10) secretion.
The aims of the present study are:
Our research efforts will focus on identifying the effects of PCV vs.VCV during OLV for thoracotomy on the followings.
- Intraoperative changes in the peak and plateau airway pressures and static and dynamic lung compliance.
- Pulmonary function tests [vital capacity and FEV1] and arterial blood gases changes during the first 3 postoperative days.
- The perioperative changes in serum levels of the proinflammatory cytokines, including IL-1, IL-6, IL8, and TNF-α and the anti-inflammatory cytokines IL-10,
- The perioperative changes in BAL levels of the concentration of proteins, IL-1, IL-6, IL8, IL-10, and TNF-α.
- The duration of postoperative ventilatory support, the time to extubation, the length of stay in post-anaesthesia care unit (PACU).
- The incidence of the major complications (respiratory failure, cardiovascular events, bleeding, and renal dysfunction).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 years (ASA physical status II-III) scheduled for elective open thoracic surgery using one lung ventilation for periods longer than 1.5 h
排除标准
- •We will exclude the patients with:
- •decompensated cardiac (>New York Heart Association II)
- •pulmonary diseases (VC or FEV1<50% of the predicted values)
- •pulmonary hypertension (mean pulmonary artery pressure [MPAP] >30 mm Hg)
- •previous lobectomy or bilobectomy in the medical history
- •those treated with immune modulators (cytostatic drugs, corticosteroids and non-steroidal anti-inflammatory drugs, vaccination, blood products), within 3 months before surgery and with symptoms of an acute inflammatory process (clinically defined or abnormal data for C-reactive protein, leukocyte count, or body temperature)
结局指标
主要结局
Determine changes in the serum levels of cytokines
时间窗: 4 months
次要结局
- Arterial blood gases, chest X- ray, pulmonary function tests, samples collection [serum and BAL] and laboratory testing for cytokine changes, the times of ventilation, extubation, ICU and hospital stay, mortality and morbidity.(10 months)