跳至主要内容
临床试验/NCT04700943
NCT04700943已完成不适用

Ultrasound Assessment of Diaphragmatic Dysfunction: General Versus Regional Anesthesia for Video-assisted Thoracoscopic Surgery Pulmonary Biopsy in Interstitial Lung Disease

University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Diaphragmatic maximal function

研究概览

简要总结

Awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome. However, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. Furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications.

To assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. The investigators measured both diaphragmatic excursion and Thickening Fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data.

详细描述

Awake thoracic surgery is a feasible and safe alternative to general anesthesia for pulmonary biopsy in interstitial lung disease patients, but there is still no evidence as to its superiority in terms of outcome.

However, there is extensive literature about the effect of anesthetic drugs and surgery on diaphragmatic function. Furthermore, in thoracic surgery, diaphragmatic dysfunction was associated with a higher occurrence of postoperative pulmonary complications.

To assess the impact of general anesthesia on diaphragmatic function, the investigators conducted an observational prospective trial. The investigators measured both diaphragmatic excursion and Thickening Fraction at baseline and 12 hours after surgery together with pulmonary function tests and gas exchange data.

The investigators divided our population into two groups: one group of patients undergoing awake thoracic surgery with epidural anesthesia, and the other group undergoing general anesthesia.

Forty-one patients were recruited and the Thickening Fraction percentage, calculated as (End Inspiratory thickness-End Expiratory thickness)/End Expiratory thickness, was evaluated by means of an ultrasound-assisted method, using a high frequency (10 MHz) linear probe.

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

入选标准

  • Patients scheduled for lung biopsy from February 2019 to September 2020

排除标准

  • pregnancy,
  • Body Mass Index >35,
  • Inability to provide informed consent,
  • American Society of Anesthesiologists physical status classification score of IV
  • Recommended postoperative ICU care

结局指标

主要结局

Diaphragmatic maximal function

时间窗: 12 hours

Measured with diaphragmatic excursion

次要结局

  • Pain scores(24 hours)
  • Postoperative Nausea and Vomiting(24 hours)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验