Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD (PredicT)

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Postoperative Complications; Lung Diseases, Obstructive

Study type: Observational

Funder types: Other

Identifiers

NCT02566343

PV4743

Details and patient eligibility

About

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.

Full 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.

Enrollment: 365 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

365 participants in 2 patient groups

COPD cohort

Description:

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

Description:

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.