Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD

Completed

• Conditions: Postoperative Complications; Lung Diseases, Obstructive

• Registration Number: NCT02566343
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Status Verified: 2016-06
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

Inclusion Criteria

• 18 years and older
• High-risk noncardiac major surgery with an anticipated operation time ≥ 120 minutes and/or planned postoperative intensive care unit admission
• Typical clinical signs for COPD (dyspnea, chronic cough, chronic sputum production, exposure to risk factors)
• Confirmed COPD (medical history) or clinical risk factors for COPD
• Positive COPD Assessment Test (CAT™)

Exclusion Criteria

• < 18 Years
• Pregnancy
• Lack of cooperation
• Inability to provide functional tests like spirometry or stairclimbing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite end point of postoperative pulmonary complications (PPC) or all cause in-hospital mortality	until hospital discharge up to 6 months after surgery

Secondary Outcome Measures

Name	Time	Method
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
Carbon dioxide (pCO2) and oxygen (pO2) partial pressures from blood gas analysis	within 1 week after extubation
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
Duration of hospitalization (days)	until hospital discharge up to 6 months after surgery
Forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) and FEV1 % predicted	within 1 week after extubation
New pulmonary radiological findings (e.g. pneumonia or pneumothorax)	until hospital discharge up to 6 months after surgery
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

Trial Locations

Locations (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany