Incidence of Diaphragmatic Dysfunction After Non-Intubated Video-Assisted Thoracoscopic Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Diaphragmatic excursion
研究概览
简要总结
The objective of this this single-center prospective longitudinal study is to evaluate the incidence of diaphragmatic dysfunction after non-intubated video-assisted thoracoscopic surgery (NIVATS).
Participant will be evaluated during surgery, 2 hours and 24 hours after surgery.
详细描述
This is a prospective longitudinal single-center study conducted on patients undergoing non-intubated video-assisted thoracoscopic surgery. The main indications for this surgery are wedge resections, pneumothorax repair, and pleural biopsies (with or without talc pleurodesis) for pleural effusion.
Except for the inclusion visit, each patient will be evaluated twice, 2 and 24 hours after the end of the surgical procedure. The data from each evaluation will be recorded by the physician in the electronic CRF
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
- •Patient aged 18 years or older
- •Patient who has read and signed the informed consent form for participation in the study
- •Patient undergoing surgery with video-assisted thoracoscopic surgery without intubation
排除标准
- •Known or detected diaphragmatic dysfunction before the intervention
- •Patient not affiliated with the French social security system
- •Patient under legal protection, guardianship, or curatorship
- •Patient already enrolled in another therapeutic study protocol (involving medications or non-drug therapies)
- •Patient in an exclusion period from a previous clinical study
- •Mental deficiency or any other reason that may hinder understanding or strict adherence to the protocol
研究组 & 干预措施
Diaphragmatic Dysfunction evaluation
干预措施: NIVATS (Procedure)
结局指标
主要结局
Diaphragmatic excursion
时间窗: Hour 24
The measurement of diaphragmatic excursion at H2 and H24 constitutes the primary evaluation criterion. Diaphragmatic excursion will be measured by ultrasound using a low-frequency probe (\< 5 MHz), either an abdominal or cardiac probe, positioned under the costal margin on the operated side and the contralateral side. To limit inter-operator variability, the patient's ultrasound evaluation will, as much as possible, be performed by the same operator. The presence of diaphragmatic dysfunction is defined by a diaphragmatic excursion of less than 1 cm.
次要结局
- Pain evaluation(Hour 24)
- Diaphragmatic thickening evaluation(Hour 24)
- postoperative complications evaluation(Hour 24)
- Pain evaluation(Hour 2)
- Diaphragmatic thickening evaluation(Hour 2)
- postoperative complications evaluation(Hour 2)