Clinical trial NCT02566343: Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD
Official title: Preoperative Diagnostic Tests for Pulmonary Risk Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Major Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases, Obstructive
Postoperative Complications
Keywords: Spirometry
Exercise Test
Blood Gas Analysis
Respiratory Function Tests
Diagnostic Techniques, Respiratory System
Surgical Procedures, Operative
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite end point of postoperative pulmonary complications (PPC) or all cause in-hospital mortality
timeFrame: until hospital discharge up to 6 months after surgery
Secondary outcomes:
measure: Forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) and FEV1 % predicted
timeFrame: within 1 week after extubation
measure: Carbon dioxide (pCO2) and oxygen (pO2) partial pressures from blood gas analysis
timeFrame: within 1 week after extubation
measure: Postoperative new respiratory symptoms (e.g. dyspnea or wheezing) or treatment for exacerbation (e.g. new systemic glucocorticosteroids or bronchodilators)
timeFrame: until hospital discharge up to 6 months after surgery
measure: New pulmonary radiological findings (e.g. pneumonia or pneumothorax)
timeFrame: until hospital discharge up to 6 months after surgery
measure: Duration of hospitalization (days)
timeFrame: until hospital discharge up to 6 months after surgery
measure: Duration of postoperative respirator support (h)
timeFrame: until hospital discharge up to 6 months after surgery
measure: Length of stay in the intensive care unit (days)
timeFrame: until hospital discharge up to 6 months after surgery
measure: Frequency of unplanned intensive care unit admission, prolonged oxygen requirement, reintubation, non-invasive ventilation (NIV) or extracorporeal lung assist
timeFrame: until hospital discharge up to 6 months after surgery
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Martin Petzoldt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Christian Zöllner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.