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临床试验/NCT03994848
NCT03994848已完成不适用

Pulmonary Prehabilitation With Incentive Spirometry in Patients Undergoing One-Lung Ventilation and the Effect on Postoperative Lung Function: A Randomized-Controlled Trial

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Lung Volumes

研究概览

简要总结

Postoperative pulmonary complications (PPCs) are the most common complication following thoracic surgery. PPCs are associated with prolonged hospital stay, increased morbidity, mortality, ICU admission, and healthcare costs (Azhar, 2015). Current preoperative optimization in this patient group includes smoking cessation and management of Chronic Obstructive Pulmonary Disease with inhaled bronchodilators and inhaled steroids as indicated. There have been studies using preoperative incentive spirometry in patients undergoing laparotomy with conflicting results, but scant data on its use in patients undergoing one-lung ventilation (Tyson, et al., 2015; Cattano, et al., 2010). A study from 2013 investigated the effectiveness of incentive spirometry in patients following thoracotomy and found conflicting results, without significant improvement in lung function or reduction in PPCs, but a larger difference in frequency of PPC was noted, indicating possible benefit to intervention and a need for further study (Agostini, et al., 2013). Volume-based incentive spirometry pre- and postoperatively has also been found to improve pulmonary function and diaphragm excursion in patients undergoing laparoscopic surgery (Alaparthi, et al., 2016).

Patients customarily receive an incentive spirometer for use postoperatively in the PACU. There is scant data in the thoracic surgery population concerning prehabilitation by dispensing the incentive spirometer at the PACT evaluation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Patients scheduled for thoracic surgery procedures involving one-lung ventilation
  • open thoracotomy
  • Video-assisted thoracoscopic surgery (VATS)
  • Robotic-assisted thoracoscopic surgery (RATS)
  • Procedures to include: Lung resection for any purpose, esophagectomy, thymectomy
  • Patients undergoing esophagectomy performed by a general surgeon
  • Patients willing and able to independently perform incentive spirometry

排除标准

  • Trauma patients
  • Lung Volume reduction surgery (LVRS)
  • In-Patients
  • Patients not undergoing one-lung ventilation
  • Patients undergoing thoracoabdominal aortic aneurysm repair
  • Transhiatal esophagectomy (does not involve one-lung ventilation)
  • Lung transplantation

结局指标

主要结局

Lung Volumes

时间窗: From the time of admission to the pre-operative holding area to 72 hours post-operatively

Mean Lung Volumes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffry B. Dobyns

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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