PredicT: Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Completed

CT.gov ID

NCT02566343

Collaborator

(none)

365

Enrollment

Location

Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases, Obstructive Postoperative Complications

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:

standardized clinical questionnaire
COPD Assessment Test (CAT™)
exercise capacity (symptom-limited stair climbing)
spirometry
capillary blood gas Analysis

Postoperative follow-up is planned between the 2nd and 5th day after extubation.

Study Design

Study Type:

Observational

Actual Enrollment :

365 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Preoperative Diagnostic Tests for Pulmonary Risk Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Major Surgery

Study Start Date :

Nov 1, 2014

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Principal Investigator: Martin Petzoldt, MD, Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Christian Zöllner, MD, Universitätsklinikum Hamburg-Eppendorf