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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268708
• Other study ID #: COCHIN2014BPCO
• Status: Completed
• Phase: N/A
• First received: August 6, 2014
• Last updated: February 17, 2016
• Start date: July 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Hôpital Cochin
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD
• Malignant Neoplasm of Thorax
• Neoplasms
• Thoracic Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Réanimation chirurgicale thoracique Hôpital Cochin	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Cochin

Country where clinical trial is conducted

France, 

References & Publications (3)

Hurst JR, Vestbo J, Anzueto A, Locantore N, Müllerova 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. — View 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. — View Citation

Wedzicha JA, Seemungal TA. COPD exacerbations: defining their cause and prevention. Lancet. 2007 Sep 1;370(9589):786-96. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Mortality		30 days	No
Secondary	Duration of total hospitalisation, and ICU hospitalisation		30 days	No
Secondary	Any other non respiratory complication	Coplications: cardiac, kiddney, sepsis.	30 days	No