Skip to main content
OpenTrials
Completed

NCT Number: NCT02268708

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

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 .

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Réanimation chirurgicale thoracique Hôpital Cochin

Paris, Île-de-France Region, 75014, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oncological pulmonary resection

Procedure

Respiratory evaluation before sugery Oncological pulmonary resection with general anesthesia. Hospitalization for post operative care

Primary outcomes

  1. 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

  1. 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.

    Time frame: 1 YEAR

  2. Mortality

    Time frame: 30 days

  3. Duration of total hospitalisation, and ICU hospitalisation

    Time frame: 30 days

  4. Any other non respiratory complication

    Time frame: 30 days

    Coplications: cardiac, kiddney, sepsis.

Sponsors and collaborators

Lead sponsor

Hôpital Cochin

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 20, 2014
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.