Prospective Study Evaluating the Effectiveness of Intraoperative Ventilation for Predicting Postoperative Air Leaks During Major Lung Resections by Conventional or Robotic Thoracoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- correlation between intraoperative air leak volume and post-operative air leakage volume
研究概览
简要总结
Air leak from lung after major pulmonary resections is alveolar-pleural microfistulas resulting from damage to the visceral pleura during lung surgery. Despite advances in stapling techniques and repair methods to ensure pulmonary tightness after excision, air leak is the most common cause of prolonged hospital stay after lung surgery, accounting for 20 to 30% of post-surgical adverse events.
Although painless, they remain a significant source of morbidity. 10 to 20% of patients may have a prolonged air leak requiring intervention. Prolonged air leak is defined as an air leakage that persists for 5 days or more. Prolonged air leak is independently associated with increased hospitalization costs of 18% to 27% according to the series reported in the literature, but also with increased costs after hospital discharge, up to 90 days postoperatively.
Traditionally, the detection of air leak at the end of surgery is done by testing the lung for submersion in saline solution. With the development of major pulmonary resection techniques by conventional or robotic thoracoscopy (with closed chest), this method has become ineffective because it requires re-ventilating the lung in a closed rib cage, which cancels the visibility of the camera. However, the frequency of these adverse events and the morbidity associated with them now induces the placement of post-operative drains, which are very painful, unlike the leak itself, which makes the pain even more complex to bear for patients.
Given the rapid transition to a minimally invasive surgical approach, having a method to detect and quantify intraoperative air leak on a closed chest is necessary in order to accelerate patients' postoperative recovery, reducing their postoperative pain while controlling the incidence of complications.
A recent study has shown that the risk of postoperative air leak is possible based exclusively on intraoperative ventilator measurements, but the data are still too scarce to rely on them extensively.
详细描述
In this NODRAIN study, we aim to evaluate the effectiveness of intraoperative ventilation for the detection of intraoperative air leak from lung. Therefore, the main objective of this study is to investigate the effectiveness of intraoperative ventilation for the prediction of postoperative air leak.
Each patient will receive intraoperative ventilation, conducted for the diagnosis of air leak in routine practice, as well as their routine post-operative care, which is the installation of drains. The demonstration of a correlation will make it possible to determine a threshold for identifying patients for whom drainage would not be necessary, thus reducing their post-operative pain, the duration and the cost of hospitalization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient with pulmonary lobectomy or Anatomical segmentectomy with closed chest (conventional or robotic thoracoscopy);
- •Patient affiliated with a health insurance scheme.
- •Person who has not objected to the collection of his/her data for the purpose of the study.
排除标准
- •Patient undergoing any type of lung resection by thoracotomy;
- •Patient with a history of thoracic surgery on the same side;
- •Patient with pulmonary fibrosis;
- •Patient from a vulnerable population as defined in Articles L.1121-5 to 8 of the French Public Health Code.
- •Patient undergoing conversion to thoracotomy;
- •Patient undergoing conversion from planned pulmonary lobectomy or anatomical segmentectomy to atypical resection, bilobectomy or pneumonectomy;
- •Drainage via two chest drains;
- •Absence of autonomous drainage system;
- •Patient not extubated at the end of the procedure;
- •Early reoperation, before drain removal, due to complications.
结局指标
主要结局
correlation between intraoperative air leak volume and post-operative air leakage volume
时间窗: From enrollment to the study completion at 4 weeks
The primary endpoint is the correlation between intraoperative air leak volume, measured by the ventilator, and postoperative air leak volume, measured by the digitalized autonomous drainage system on the patient's postoperative drain after extubation.
次要结局
未报告次要终点