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临床试验/NCT04507594
NCT04507594已完成不适用

Measurement of Diaphragmatic Dysfunction in Patients Undergoing Thoracic Resection Surgery for Lung- or Esophageal Cancer

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年8月6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
40
试验地点
1
主要终点
Change in excursion of the diaphragm

研究概览

简要总结

This study aims to measure diaphragmatic dysfunction with ultrasonography and nerve stimulation of the phrenicus nerve, in patients undergoing thoracic surgery for lung and esophageal cancer, and correlate measures of diaphramatic function to clinical postoperative endpoints.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled thoracic resection Surgery for lung- or esophagus cancer. For lung cancer patients, at least one lung lobe has to scheduled for resection

排除标准

  • Known Diaphragmatic Dysfunction
  • Neuromuscular Disease
  • Pleural Effusion > 1cm
  • Pneumothorax
  • Known Phrenic Nerve Palsy

结局指标

主要结局

Change in excursion of the diaphragm

时间窗: Prior to surgery to 14 days after surgery

Ultrasonographic measure with M-mode of Diaphragmatic Excursion on right hemidiaphragm

次要结局

  • Change in Diaphragmatic Thickening Fraction(Prior to surgery to 14 days after surgery)
  • Change in peak flow(Prior to surgery to 14 days after surgery)
  • Ultrasonographic measure of the difference in Intrathoracic Area(Prior to surgery to 14 days after surgery)
  • Change in forced expired volume within the first second (FEV1)(Prior to surgery to 14 days after surgery)
  • Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve(Prior to surgery to 14 days after surgery)
  • Postoperative Pulmonary Complications(Prior to surgery to 30 days after surgery)
  • Change in forced vital capacity (FEV)(Prior to surgery to 14 days after surgery)
  • Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve(Prior to surgery to 14 days after surgery)
  • Change in 6 Minutes Walk Test(Prior to surgery to 14 days after surgery)
  • Accumulated Opiod Use after Surgery(Prior to surgery to 14 days after surgery)
  • Admission days at the Intensive Care Unit after Surgery(Prior to surgery to 60 days after surgery)
  • Accumulated Admission Days at any Hospital(Prior to surgery to 60 days after surgery)
  • Change in Intercostal Muscle Thickening Fraction(Prior to surgery to 14 days after surgery)
  • Change in visual analogue scale score(Prior to surgery to 14 days after surgery)
  • Number of Admissions after Discharge from the Surgical Department(Prior to surgery to 60 days after surgery)

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Juhl-Olsen

Associate Professor

Aarhus University Hospital

研究点 (1)

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