Lung Diseases, ObstructivePredicTNCT02566343
Preoperative Diagnostic Tests for Pulmonary Risk Assessment in COPD
An observational study of Lung Diseases, Obstructive and Postoperative Complications, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Obstructive, Postoperative Complications
- How many people
- 365 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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™)
Who cannot join
- < 18 Years
- Pregnancy
- Lack of cooperation
- Inability to provide functional tests like spirometry or stairclimbing
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: 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.
Read the 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.
- Keywords
- Spirometry, Exercise Test, Blood Gas Analysis, Respiratory Function Tests, Diagnostic Techniques, Respiratory System, Surgical Procedures, Operative
- Medical subject headings
- Lung Diseases, Obstructive, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Composite end point of postoperative pulmonary complications (PPC) or all cause in-hospital mortality
Measured: 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
Measured: within 1 week after extubation
Carbon dioxide (pCO2) and oxygen (pO2) partial pressures from blood gas analysis
Measured: 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)
Measured: until hospital discharge up to 6 months after surgery
New pulmonary radiological findings (e.g. pneumonia or pneumothorax)
Measured: until hospital discharge up to 6 months after surgery
Duration of hospitalization (days)
Measured: until hospital discharge up to 6 months after surgery
Duration of postoperative respirator support (h)
Measured: until hospital discharge up to 6 months after surgery
Length of stay in the intensive care unit (days)
Measured: 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
Measured: until hospital discharge up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Diseases, ObstructiveStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Petzoldt, MD, Principal investigator, Universitätsklinikum Hamburg-EppendorfChristian Zöllner, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566343
- Sponsor's protocol ID
- PV4743
- Acronym
- PredicT
- Status last verified
- Jun 2016
- First submitted
- 21 Sep 2015
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 23287892
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Diagnostic Tests for Pulmonary Risk Assessment in Patients With Chronic Obstructive Pulmonary Disease (COPD) Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT02566343
- Acronym / sponsor ID
- PredicT / PV4743
- Keywords
- Spirometry, Exercise Test, Blood Gas Analysis, Respiratory Function Tests, Diagnostic Techniques, Respiratory System, Surgical Procedures, Operative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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™)
Key exclusion criteria (4 listed)
- < 18 Years
- Pregnancy
- Lack of cooperation
- Inability to provide functional tests like spirometry or stairclimbing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Forced expiratory volume in one second to forced vital capacity ratio (FEV1/FVC) and FEV1 % predicted
Time frame: within 1 week after extubation
Carbon dioxide (pCO2) and oxygen (pO2) partial pressures from blood gas analysis
Time frame: 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)
Time frame: until hospital discharge up to 6 months after surgery
New pulmonary radiological findings (e.g. pneumonia or pneumothorax)
Time frame: until hospital discharge up to 6 months after surgery
Duration of hospitalization (days)
Time frame: until hospital discharge up to 6 months after surgery
Duration of postoperative respirator support (h)
Time frame: until hospital discharge up to 6 months after surgery
Length of stay in the intensive care unit (days)
Time frame: 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
Time frame: until hospital discharge up to 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Background: PubMed 23287892Gupta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Petzoldt, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
Christian Zöllner, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, Obstructive and Postoperative Complications, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02566343, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.