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

NCT ID: NCT02268708

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-02-29

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 .

Conditions

COPD; Malignant Neoplasm of Thorax

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD

Patients:

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

Oncological pulmonary resection

Intervention Type: PROCEDURE

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

Interventions

Oncological pulmonary resection

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Cochin

OTHER

Sponsor Role: lead

Responsible Party

Demiri Suela

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suela Demiri, Resident

Role: PRINCIPAL_INVESTIGATOR

Locations

Réanimation chirurgicale thoracique Hôpital Cochin

Paris, Île-de-France Region, France

Countries

France

References

Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.

Reference Type: BACKGROUND

PMID: 20843247 (View on PubMed)

Wedzicha JA, Seemungal TA. COPD exacerbations: defining their cause and prevention. Lancet. 2007 Sep 1;370(9589):786-96. doi: 10.1016/S0140-6736(07)61382-8.

Reference Type: RESULT

PMID: 17765528 (View on PubMed)

Wan ES, DeMeo DL, Hersh CP, Shapiro SD, Rosiello RA, Sama SR, Fuhlbrigge AL, Foreman MG, Silverman EK. Clinical predictors of frequent exacerbations in subjects with severe chronic obstructive pulmonary disease (COPD). Respir Med. 2011 Apr;105(4):588-94. doi: 10.1016/j.rmed.2010.11.015. Epub 2010 Dec 10.

Reference Type: RESULT

PMID: 21145719 (View on PubMed)

Other Identifiers

COCHIN2014BPCO

Identifier Type: -

Identifier Source: org_study_id