Clinical trial NCT02268708: Evaluation of Post-operative Respiratory Complications After Thoracic Surgery in Patients With COPD
Official title: Evaluation of Post-operative Respiratory Complications After Thoracic Surgery in Patients With COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Malignant Neoplasm of Thorax
Keywords: COPD
Surgery, Thoracic
Lead sponsor: Hôpital Cochin
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 .


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)

Primary outcomes:
measure: Prevalence of pulmonary postoperative complications lung resection in COPD patients.
timeFrame: 1 YEAR
Secondary outcomes:
measure: 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.
timeFrame: 1 YEAR
measure: Mortality
timeFrame: 30 days
measure: Duration of total hospitalisation, and ICU hospitalisation
timeFrame: 30 days
measure: Any other non respiratory complication
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Réanimation chirurgicale thoracique Hôpital Cochin
state: Ile de France
Study officials:
name: Suela Demiri, Resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.