Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD

NCT02566343 | Completed

• 1 other identifier: PV4743
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases, Obstructive; Postoperative Complications

Keywords

Spirometry; Exercise Test; Blood Gas Analysis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Surgical Procedures, Operative

Outcome Measures

Primary Outcomes (1)

• Composite end point of postoperative pulmonary complications (PPC) or all cause in-hospital mortality

  until hospital discharge up to 6 months after surgery

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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™)

You may not qualify if:

• \< 18 Years
• Pregnancy
• Lack of cooperation
• Inability to provide functional tests like spirometry or stairclimbing

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related 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.

  PMID: 23287892 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Obstructive; Postoperative Complications

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Petzoldt, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Christian Zöllner, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: October 2, 2015
• Study Start: November 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: June 24, 2020

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)