Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD

Postoperative Complications Clinical Trial

— PredicT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566343
• Other study ID #: PV4743
• Status: Completed
• Start date: November 2014
• Est. completion date: July 2016

Study information

• Verified date: June 2016
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Postoperative Complications

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite end point of postoperative pulmonary complications (PPC) or all cause in-hospital mortality		until hospital discharge up to 6 months after surgery
Secondary	Forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) and FEV1 % predicted		within 1 week after extubation
Secondary	Carbon dioxide (pCO2) and oxygen (pO2) partial pressures from blood gas analysis		within 1 week after extubation
Secondary	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
Secondary	New pulmonary radiological findings (e.g. pneumonia or pneumothorax)		until hospital discharge up to 6 months after surgery
Secondary	Duration of hospitalization (days)		until hospital discharge up to 6 months after surgery
Secondary	Duration of postoperative respirator support (h)		until hospital discharge up to 6 months after surgery
Secondary	Length of stay in the intensive care unit (days)		until hospital discharge up to 6 months after surgery
Secondary	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