Effects of Intraoperative Continuous Airway Pressure (CPAP) on the Inflammatory Response of the Lung With Cancer Undergoing Lobectomy. A Randomised Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.
研究概览
简要总结
This is a randomized placebo-controlled trial studying the effects of intraoperative continuous airway pressure (CPAP) on the inflammatory response of the lung with cancer undergoing lobectomy.
详细描述
Pulmonary lobectomy induces an inflammatory response of this lung caused by intraoperative atelectasis and re-expansion. This inflammatory response can be attenuated with treatment, also decreasing postoperative pulmonary complications (PPC). Thus, avoiding complete atelectasis with partial insufflation of the lung during surgery could be useful to decrease inflammatory response and PPC.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18-80 aged) with American Society of Anesthesiologists physical status I-III, scheduled to undergo elective thoracic surgery with lung resection performed through thoracotomy, and requiring OLV (one lung ventilation)during surgery.
排除标准
- •Ongoing treatment with any dose of systemic or topical steroids, acute pulmonary or extrapulmonary infections (elevated C-reactive protein [CRP]), history of recurrent pneumothoraces, previous thoracic surgery.
结局指标
主要结局
Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.
时间窗: From preoperative to postoperative (24h) period.
Alveolar and plasmatic cytokines measured before and after atelectasis and re-expansion.
次要结局
- Alveolar MICA(From preoperative to postoperative period (24h))
- Postoperative pulmonary complications (PPC).(Participants will be followed for the duration of hospital stay, an expected average of 10 days.)
- CT-Scan(22-24h after surgery)
研究者
Lluís Gallart
MD
Parc de Salut Mar