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

NCT02268708 | Completed

• 1 other identifier: COCHIN2014BPCO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

COPD; Surgery, Thoracic

Outcome Measures

Primary Outcomes (1)

• Prevalence of pulmonary postoperative complications lung resection in COPD patients.

  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.

  1 YEAR

Secondary Outcomes (4)

• 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 Arms (1)

COPD

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

Procedure: Oncological pulmonary resection

Interventions

Oncological pulmonary resection PROCEDURE

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

COPD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital Cochin: lead

Study Sites (1)

Réanimation chirurgicale thoracique Hôpital Cochin

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

Location

Related Publications (3)

• 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.

  PMID: 20843247 BACKGROUND

• 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.

  PMID: 17765528 RESULT

• 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.

  PMID: 21145719 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suela Demiri, Resident

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: October 20, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

FR (1)