NCT02566343

Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD

Preoperative Diagnostic Tests for Pulmonary Risk Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Major Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 365 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective study intends to investigate the incidence of postoperative pulmonary complications (PPC) or in-hospital mortality in patients with COPD or at risk for COPD undergoing high-risk noncardiac major surgery and to identify relevant risk factors. This study aims to quantify and compare the diagnostic performance of preoperative functional tests, exercise capacity, clinical assessment tests and predictive scoring systems to predict PPC or in-hospital mortality in these patients.

Detailed description

COPD is associated with high perioperative morbidity and mortality and PPC frequently occur in these patients. However, concepts for preoperative pulmonary risk assessment and the predictive value of routine preoperative exercise capacity, clinical assessment and pulmonary function tests are still poorly characterized. Objectives: * To determine the incidence of the composite end point of PPC or all cause in-hospital mortality in patients with confirmed COPD (spirometry) and patients with clinical risk factors in whom spirometry disproved COPD. * To determine the predictive value of exercise capacity, clinical assessment tests, pulmonary function tests and predictive scoring systems to predict the composite end point in these patients. * To identify relevant risk factors and predictors associated with the composite end point. Methodology: Prospective single-centre observational study All patients receive a structured preoperative pulmonary risk assessment with: 1. standardized clinical questionnaire 2. COPD Assessment Test (CAT™) 3. exercise capacity (symptom-limited stair climbing) 4. spirometry 5. capillary blood gas Analysis Postoperative follow-up is planned between the 2nd and 5th day after extubation.

Conditions

• Lung Diseases, Obstructive
• Postoperative Complications

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-10-02
• Last updated: 2020-06-24

Locations

1 site across 1 country: Germany