Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

365 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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

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Lung Diseases, Obstructive Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to 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.

No interventions assigned to this group

Eligibility Criteria

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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™)