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

Completed

• Conditions: Malignant Neoplasm of Thorax; COPD
• Interventions: Procedure: Oncological pulmonary resection

• Registration Number: NCT02268708
• Lead Sponsor: Hôpital Cochin

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-20
• Primary Completion: 2015-06
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD	Oncological pulmonary resection	Patients: \>18 years old COPD: FEV/FEV1\<80% in respiratory evaluation who have un oncological pulmonary resection in Cochin Hospital Paris France

Primary Outcome Measures

Name	Time	Method
Prevalence of pulmonary postoperative complications lung resection in COPD patients.	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 Outcome Measures

Name	Time	Method
Mortality	30 days
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
Duration of total hospitalisation, and ICU hospitalisation	30 days
Any other non respiratory complication	30 days	Coplications: cardiac, kiddney, sepsis.

Trial Locations

Locations (1)

Réanimation chirurgicale thoracique Hôpital Cochin; 🇫🇷 Paris, Ile de France, France