Application of CPAP to Reduce Complications and Improve Treatment of Radiofrequency Ablation of Lung Cancer Under Conscious Sedation. A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety
研究概览
简要总结
The project aims to study whether the application of a continuous positive airway pressure (CPAP) of 4 cm water vapor is a safe method in pulmonary radiofrequency intervention (PRF) lung cancer under conscious sedation compared with placebo. And, assess whether CPAP prevents atelectasis formation and consequently reduces the potential complications of PRF and improves procedural success
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female aged 18 years and older
- •Patient with a scheduled intervention for ablation of pulmonary malignant tumor with radiofrequency .
- •Patient able to undergo tests and examinations required by the study.
排除标准
- •Patients with CPAP intolerance test.
- •Patients with progressive disease in which local treatment is not applicable
- •Patients with intercurrent process (pleural effusion, pneumonia, ...).
- •Patient unable to understand the proceedings.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
CPAP +4 cm H2O
CPAP +4 cm H2O pressure using ResMedTM face mask
干预措施: RESMED AUTOSET S9 (Device)
ShamCPAP
shamCPAP using ResMedTM CPAP face mask modified for technical sham
干预措施: RESMED AUTOSET S9 (Device)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety
时间窗: thirty days
Patients with any of the following complications Pulmonary over-distention along intervention Pneumothorax along intervention Bronchial fistulas measures Computed tomography (CT)1, CT2 and CT3 Vomiting along intervention Decrease in MAP (mean arterial pressure) \> 20% measured in the intraoperative period Assay of each of the previous complications
次要结局
- Treatment success(Measurement time: CT3)
- Prevention of atelectasis.(during surgery)
- Decrease associated complications with PFR. Measurement times: intraoperative, PACU (post-anesthesic care unit), hospital discharge, day 15 and day 30.(thirty days)
- Predictors factors of the occurrence of complications during PRA (pulmonary radiofrequency ablation).(thirty days)
研究者
Sara Varea
Clinical Research Manager
Fundacion Clinic per a la Recerca Biomédica