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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Lung Diseases, Obstructive

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.

• Study Type: Observational
• Enrollment (Actual): 365

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Christian Zöllner, MD, Universitatsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: September 21, 2015
• First Submitted That Met QC Criteria: October 1, 2015
• First Posted (ESTIMATE): October 2, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Spirometry; Surgical Procedures, Operative; Respiratory Function Tests; Exercise Test; Blood Gas Analysis; Diagnostic Techniques, Respiratory System
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Postoperative Complications
• Other Study ID Numbers: PV4743

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO