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Clinical Trials/NCT02268708
NCT02268708
Completed
Not Applicable

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

Hôpital Cochin1 site in 1 country100 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Hôpital Cochin
Enrollment
100
Locations
1
Primary Endpoint
Prevalence of pulmonary postoperative complications lung resection in COPD patients.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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 .

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
February 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hôpital Cochin
Responsible Party
Principal Investigator
Principal Investigator

Demiri Suela

Resident

Hôpital Cochin

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Prevalence of pulmonary postoperative complications lung resection in COPD patients.

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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