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临床试验/NCT02268708
NCT02268708已完成不适用

Evaluation of Post-operative Respiratory Complications After Thoracic Surgery in Patients With COPD

Hôpital Cochin1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Prevalence of pulmonary postoperative complications lung resection in COPD patients.

研究概览

简要总结

Evaluation of post-operative respiratory complications after thoracic surgery for pulmonary resection in patients with COPD

Introduction: Postoperative pulmonary complications following pulmonary resection occur in 12-40% of cases. Some risk factors such as COPD are well identified. It has been shown that COPD patients with a history of frequent exacerbations are more likely to develop exacerbations. No study has evaluated the rate of patients called 'frequent exacerbators' among COPD patients requiring pulmonary resection and the relations between exacerbations history and incidence of acute respiratory postoperative complications.

The main objective is to determine the frequency of pulmonary postoperative complications (atelectasis, acute respiratory failure, pneumonia) following lung resection in COPD patients. The secondary objectives are to determine the frequency of extra pulmonary postoperative complications and the prevalence of the 'frequent exacerbator' phenotype in this population, as well as its relation with the risk of post-operative complications.

Materials and Methods: This is a prospective, observational, single-center study, of patients with COPD hospitalized for elective thoracic surgery in the center of Thoracic Surgery, Hôpital Cochin. The inclusion criteria are: male or female aged more than 40 years, permanent airflow obstruction as defined by an FEV/FVC ratio < 70% after bronchodilator. Collected data will be: COPD symptoms (dyspnea score, exacerbations) by a questionnaire given to the patient during the anesthesia consultation, COPD severity scores, comorbidities, per operative data, postoperative complications, hospitalization and intra-hospital mortality.

Perspectives: This work will provide information on the risk of postoperative complications in patients with COPD and the influence of the 'frequent exacerbator' phenotype. This will help adapting preventive care to the COPD subtype .

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
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female >40 years old
  • COPD permanent airflow obstruction as defined by an FEV/FVC ratio < 70% after bronchodilator
  • Hospitalized for elected surgical pulmonary resction

排除标准

  • Pregnancy
  • Patient under Long duration Oxygen
  • Questionnaire information impossible to understand (because of language)

结局指标

主要结局

Prevalence of pulmonary postoperative complications lung resection in COPD patients.

时间窗: 1 YEAR

Evaluate the prevalence of atelectasis, acute respiratory failure and post operative pneumonia after thoracic surgery for lung resection in COPD (Chronic Obstructive Pulmonary Disease) patients.

次要结局

  • It is to determine the prevalence of the 'frequent exacerbator' phenotype in this COPD population, as well as its relation with the risk of post-operative complications.(1 YEAR)
  • Mortality(30 days)
  • Duration of total hospitalisation, and ICU hospitalisation(30 days)
  • Any other non respiratory complication(30 days)

研究者

发起方
Hôpital Cochin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Demiri Suela

Resident

Hôpital Cochin

研究点 (1)

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