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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.
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:
Methodology:
Prospective single-centre observational study
All patients receive a structured preoperative pulmonary risk assessment with:
Postoperative follow-up is planned between the 2nd and 5th day after extubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD cohort | confirmed COPD: 240 patients with COPD confirmed by spirometry undergoing high-risk noncardiac major surgery in the University Medical Center Hamburg-Eppendorf will be included in this group. | ||
| Control cohort | disproved COPD: 80 patients without COPD (clinical risk factors but negative spirometry) undergoing high-risk noncardiac major surgery will be included as a control group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Composite end point of postoperative pulmonary complications (PPC) or all cause in-hospital mortality | until hospital discharge up to 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) and FEV1 % predicted | within 1 week after extubation | |
| Carbon dioxide (pCO2) and oxygen (pO2) partial pressures from blood gas analysis | within 1 week after extubation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for major surgery, who present in the pre-assessment clinic of the University Medical Center Hamburg-Eppendorf during the study recruitment period, will be screened for eligibility. Patients with typical clinical signs and a positive COPD Assessment Test (CAT™) qualify for spirometry. After informed consent 80 patients with disproved COPD (FEV1/FVC ratio ≥ 0.70) and 240 patients with confirmed COPD (FEV1/FVC ratio < 0.70) will consecutively be analysed.
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| Name | Affiliation | Role |
|---|---|---|
| Martin Petzoldt, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Christian Zöllner, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23287892 | Background | Gupta H, Ramanan B, Gupta PK, Fang X, Polich A, Modrykamien A, Schuller D, Morrow LE. Impact of COPD on postoperative outcomes: results from a national database. Chest. 2013 Jun;143(6):1599-1606. doi: 10.1378/chest.12-1499. |
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| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Postoperative new respiratory symptoms (e.g. dyspnea or wheezing) or treatment for exacerbation (e.g. new systemic glucocorticosteroids or bronchodilators) | until hospital discharge up to 6 months after surgery |
| New pulmonary radiological findings (e.g. pneumonia or pneumothorax) | until hospital discharge up to 6 months after surgery |
| Duration of hospitalization (days) | until hospital discharge up to 6 months after surgery |
| Duration of postoperative respirator support (h) | until hospital discharge up to 6 months after surgery |
| Length of stay in the intensive care unit (days) | until hospital discharge up to 6 months after surgery |
| Frequency of unplanned intensive care unit admission, prolonged oxygen requirement, reintubation, non-invasive ventilation (NIV) or extracorporeal lung assist | until hospital discharge up to 6 months after surgery |