Assessment of Air Contamination Risk by Sars-Cov2 During Visceral Surgery in COVID19 Patients: Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Air contamination
研究概览
简要总结
Sars-Cov2 has been found in the digestive tract, as well as the respiratory tract. Protection of health care workers during surgery has been increased and some guidelines advocate for abandoning laparoscopy in COVID19 patients for fear of contamination, evenghtough this does not benefit the patient. However, Sars-Cov2 contamination risk during visceral surgery remains unknown. Inadequate protection is unnecessary costful and can be inefficient if too binding. Our hypotheses are that 1) Sars-Cov 2 can travel through droplet and air during visceral surgery. 2) Laparoscopy, because of the pneumoperitoneum and its leaks, warrant more air contamination whereas laparotomy warrant more droplet contamination, which would justified increased protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Documented Sars-Cov2 infection (nasopharyngeal swab, tracheal sampling, thoracic CT, serology)
- •Need of visceral surgery (laparoscopy or laparotomy)
- •Signed informed consent
- •Social coverage
- •Patient who agrees to be included in the study and who signs the informed consent form
- •Patient affiliated to a healthcare insurance plan
- •Patient willing to comply with study's requirements
排除标准
- •Need of another type of surgery during the same procedure
- •Mentally unbalanced patients, under supervision or guardianship
- •Patient who does not understand French/ is unable to give consent
- •Patient not affiliated to a French or European healthcare insurance
- •Patient incarcerated
结局指标
主要结局
Air contamination
时间窗: 10 minutes after incision if no opening of the digestive lumen, or 10 minutes after opening of the digestive tract
Composite criteria: "50cm above the operating site" and/or "1m50 from the operating site" and/or "3m from the operating site"
次要结局
- Biological fluids(During the procedure, an average 2 hours 30 min)
- Opening of the digestive tract(At the end of the intervention,an average 2 hours)
- Pneumoperitoneum(At the end of the procedure,an average 2 hours 30 min)
- Environment contamination(At the end of surgery, an average 1 hour 30 min)
- Surgical approach(At the end of the intervention, an average 2 hours)