Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography in Intensive Care Patients Undergoing Epigastric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change of regional ventilation partition (ROI analysis in 8 pulmonary ROIs) from preoperative to postoperative state.
研究概览
简要总结
The purpose of this study is to determine whether Electrical Impedance Tomography can be used as sensitive and specific predictor in the detection of postoperative pulmonary complications (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion, pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia, spasms and obstructions of the airway) in patients undergoing epigastric surgery.
详细描述
- Study cycle:
- Check of criteria of inclusion/exclusion
- Informed consent
- Recording preoperative data via paper case report form
- Preoperative EIT measurement
- Postoperative EIT measurement
- Recording postoperative data via paper case report form
Patients therapy and any diagnostic investigation during hospital stay (apart from EIT measurement) are performed appropriate to patients individual clinical needs and are independent from participation in this clinical trial. As PPC may result from surgical complications (e.g. intra- /postoperative bleeding, anastomotic leak, infection of the wound, injury of neighboring organs) they are monitored.
- Statistical analysis:
Sample size:
After consultation of Johannes-Gutenberg-University Institute of Medical Biometry and Epidemiology the following procedure was developed: Pre-analysis with 20 patients, then determination of definitive sample size (advised 80 patients).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •age > 17 years
- •no participation in another trial
- •mental and physical state allow written consent
- •elective epigastric surgery by laparotomy in general anesthesia (e.g. gastrectomy, splenectomy, pancreatic surgery, liver surgery/hemihepatectomy, cholecystectomy)
排除标准
- •age < 18 years
- •in women: pregnancy
- •missing or disability for giving written consent
- •emergency patients
- •patients after cardiac surgery less than 3 months ago
- •patients after pulmonary lobectomy during lifetime
- •patients with cardiac stimulator/defibrillator or any other implant with electric activity
- •patients with cutaneous lesions or bandage in the area of EIT electrode placement
- •patients with instability of the spine
- •body mass index > 50
结局指标
主要结局
Change of regional ventilation partition (ROI analysis in 8 pulmonary ROIs) from preoperative to postoperative state.
时间窗: 1.) First EIT-measure: Preoperative Day; 2.) Second EIT-measure: Day of Operation (after extubation) or in between Postoperative Day 1-7 (in case of deferred extubation)
Comparison of the changed regional ventilation partition to the occurence of postoperative pulmonary complications =\> calculation of sensitivity and specifity of the primary outcome measure to predict PPC. Statistical analysis: receiver operating characteristic (ROC curve).
次要结局
- Appearance of all specific forms of PPC (Postoperative Pulmonary Complications) within postoperative day 1-7(1 week)
- Ventilator-obligatory-free days(1 week)
- Outcome (e.g. mortality, time of intensive care therapy, ventilator-obligatory-free days on Postoperative Day 1-7 Postoperative EIT-measure is predictive for patients outcome(1 week)
- Time of intensive care therapy(1 week)
- Postoperative EIT-measured regional ventilation distribution (ROI analysis in 8 pulmonary ROIs)(1 week)
研究者
Dr. med. Michael Schuster
Dr. med.
Johannes Gutenberg University Mainz