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Completed

NCT Number: NCT02566343

Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: until hospital discharge up to 6 months after surgery

Secondary outcomes

  1. Forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) and FEV1 % predicted

    Time frame: within 1 week after extubation

  2. Carbon dioxide (pCO2) and oxygen (pO2) partial pressures from blood gas analysis

    Time frame: within 1 week after extubation

  3. Postoperative new respiratory symptoms (e.g. dyspnea or wheezing) or treatment for exacerbation (e.g. new systemic glucocorticosteroids or bronchodilators)

    Time frame: until hospital discharge up to 6 months after surgery

  4. New pulmonary radiological findings (e.g. pneumonia or pneumothorax)

    Time frame: until hospital discharge up to 6 months after surgery

  5. Duration of hospitalization (days)

    Time frame: until hospital discharge up to 6 months after surgery

  6. Duration of postoperative respirator support (h)

    Time frame: until hospital discharge up to 6 months after surgery

  7. Length of stay in the intensive care unit (days)

    Time frame: until hospital discharge up to 6 months after surgery

  8. Frequency of unplanned intensive care unit admission, prolonged oxygen requirement, reintubation, non-invasive ventilation (NIV) or extracorporeal lung assist

    Time frame: until hospital discharge up to 6 months after surgery

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: PredicT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2015
Registry last updated
Jun 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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