Exercise TestNCT05502263
Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates
An observational study of Exercise Test and Thoracic Cancer, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
Anatomic lung resection is the treatment of choice for the management of cancerous lung nodules Non-Small-Cell Lung Carcinoma (NSCLC). Systematic functional evaluation can reduce the risk of mortality and morbidity of candidates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise Test, Thoracic Cancer
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2022to 30 Oct 2022
- 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: Lobectomy or Segmentectomy or Wedge Resection for a patient Non-Small Cell Lung cancer patient
Who may be able to join
None listed.
Who cannot join
- pulmonary resection for diagnostic
- pneumonectomies and any extensive resections (chest wall-associated resections, Pancoast tumors, resection of the atrium or superior vena cava, resection of the diaphragm, spinal resection, pleuro-pneumonectomy, tracheal sleeve pneumonectomy, intrapericardial pneumonectomy), as well as metastases, benign lesions, and any other non-oncologic pulmonary resections
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Erasme Hospital
Brussels, 1070
Alexis Gillet, Msc, 025558386, alexis.gillet@erasme.ulb.ac.be
Forton Kevin, PhD, 025555016, kevin.forton@ulb.be
About this study
Official title: Interest of Maximal Oxygen Uptake and Ventilatory Inefficiency (VE/VCO2 Slope) Measured During Cardiopulmonary Exercise Test on Morbidity and Mortality of Lung Resection Candidates
Anatomic lung resection is the treatment of choice for the management of cancerous lung nodules Non-Small-Cell Lung Carcinoma (NSCLC). Systematic functional evaluation can reduce the risk of mortality and morbidity of candidates. Scientific societies recommend a cardiac and spirometry evaluation (including pulmonary diffusion capacity). In this context, patients with FEV1 or less than 80% of the predicted value are subjected to a more thorough evaluation of the physical physical capacity by cardiopulmonary exercise test (CPET) to determine VO2 max (Brunelli et al 2009). Patients with a VO2 max <35% of predicted values or <10ml/kg/min, or a postoperative predicted value of DLCO or FEV1(ppoDLCO, ppoVEMS) less than 30% associated with a postoperative VO2max less than 35% or 10 ml/min/kg should be offered an alternative treatment option (Begum et al 2016). In contrast, a VO2max greater than 20ml/min/kg is considered at low surgical risk (Brunelli et al 2009).
For patients with a VO2 max between 10 and 20ml/kg/min, operability depends on the extent of the resection. In this group of patients, other parameters measured with CPET could be used to optimize the selection of patients given the inability of some the inability of some patients to provide a maximal effort, thus resulting in a sub-maximal evaluation of physical capacity.
The VE/VCO2 slope, ventilatory equivalents or chronotropic recovery are parameters classically used in classically used in heart failure and have recently been shown to be independent prognostic factors as independent prognostic factors for 90-day and 2-year mortality after anatomical lung resection. Moreover, these factors do not depend on the maximality of the test and could again help us to risk-stratify for a sub-maximal and therefore not optimal test.
- Conditions
- Exercise Test, Thoracic Cancer
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 |
|---|---|---|
| moderate/high risk | FEV and/or DLCO <80% And VO2peak <20ml/kg.min or <75% predicted value | |
| Control | FEV and DLCO >80% and VO2peak > 20ml/kg.min or >75% predicted value |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
death
Measured: within 30 days after surgery
Mortality
death
Measured: within 12 months after surgery
Major respiratory complication in hospital
pneumonia (chest roentgenogram infiltrates/consolidation, leukocytosis, fever)
- respiratory failure needng mechanical ventilation for longer than 48 hours, adult respiratory distress syndrome
Measured: within 30 days after surgery
Minor respiratory complication in hospital
air leak >5 day (Patient experienced a postoperative air leak for >5 days),atelectasis requiring bronchoscopy, atrial or ventricular arrhythmia, Empyema, Wound infection, delirium, renal failure
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 May 2022
- Primary completion1 Sep 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
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 Exercise TestStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Forton, Université Libre de Bruxelles
- Investigators
- Kevin Forton, PhD, Principal investigator, Erasme University Hospital ULB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05502263
- Sponsor's protocol ID
- 2021293
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 16 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brunelli A, Belardinelli R, Pompili C, Xiume F, Refai M, Salati M, Sabbatini A. Minute ventilation-to-carbon dioxide output (VE/VCO2) slope is the strongest predictor of respiratory complications and death after pulmonary resection. Ann Thorac Surg. 2012 Jun;93(6):1802-6. doi: 10.1016/j.athoracsur.2012.03.022. Epub 2012 May 4.
PubMed 22560968
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Maximal Oxygen Uptake and Ventilatory Inefficiency (VE/VCO2 Slope) Measured During Cardiopulmonary Exercise Test on Morbidity and Mortality of Lung Resection Candidates
- ClinicalTrials.gov ID
- NCT05502263
- Acronym / sponsor ID
- 2021293
- Conditions
- Exercise Test, Thoracic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 16 Aug 2022 (actual)
- 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.
Anatomic lung resection is the treatment of choice for the management of cancerous lung nodules Non-Small-Cell Lung Carcinoma (NSCLC). Systematic functional evaluation can reduce the risk of mortality and morbidity of candidates. Scientific societies recommend a cardiac and spirometry evaluation (including pulmonary diffusion capacity). In this context, patients with FEV1 or less than 80% of the predicted value are subjected to a more thorough evaluation of the physical physical capacity by cardiopulmonary exercise test (CPET) to determine VO2 max (Brunelli et al 2009). Patients with a VO2 max <35% of predicted values or <10ml/kg/min, or a postoperative predicted value of DLCO or FEV1(ppoDLCO, ppoVEMS) less than 30% associated with a postoperative VO2max less than 35% or 10 ml/min/kg should be offered an alternative treatment option (Begum et al 2016). In contrast, a VO2max greater than 20ml/min/kg is considered at low surgical risk (Brunelli et al 2009).
For patients with a VO2 max between 10 and 20ml/kg/min, operability depends on the extent of the resection. In this group of patients, other parameters measured with CPET could be used to optimize the selection of patients given the inability of some the inability of some patients to provide a maximal effort, thus resulting in a sub-maximal evaluation of physical capacity.
The VE/VCO2 slope, ventilatory equivalents or chronotropic recovery are parameters classically used in classically used in heart failure and have recently been shown to be independent prognostic factors as independent prognostic factors for 90-day and 2-year mortality after anatomical lung resection. Moreover, these factors do not depend on the maximality of the test and could again help us to risk-stratify for a sub-maximal and therefore not optimal test.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| moderate/high risk | – | –FEV and/or DLCO <80% And VO2peak <20ml/kg.min or <75% predicted value |
| Control | – | –FEV and DLCO >80% and VO2peak > 20ml/kg.min or >75% predicted value |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lobectomy or Segmentectomy or Wedge Resection for a patient Non-Small Cell Lung cancer patient
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- pulmonary resection for diagnostic
- pneumonectomies and any extensive resections (chest wall-associated resections, Pancoast tumors, resection of the atrium or superior vena cava, resection of the diaphragm, spinal resection, pleuro-pneumonectomy, tracheal sleeve pneumonectomy, intrapericardial pneumonectomy), as well as metastases, benign lesions, and any other non-oncologic pulmonary resections
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
Mortality
Time frame: within 30 days after surgery
death
Mortality
Time frame: within 12 months after surgery
death
Major respiratory complication in hospital
Time frame: within 30 days after surgery
pneumonia (chest roentgenogram infiltrates/consolidation, leukocytosis, fever) * respiratory failure needng mechanical ventilation for longer than 48 hours, adult respiratory distress syndrome
Minor respiratory complication in hospital
Time frame: within 30 days after surgery
air leak >5 day (Patient experienced a postoperative air leak for >5 days),atelectasis requiring bronchoscopy, atrial or ventricular arrhythmia, Empyema, Wound infection, delirium, renal failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Background: PubMed 22560968Brunelli A, Belardinelli R, Pompili C, Xiume F, Refai M, Salati M, Sabbatini A. Minute ventilation-to-carbon dioxide output (VE/VCO2) slope is the strongest predictor of respiratory complications and death after pulmonary resection. Ann Thorac Surg. 2012 Jun;93(6):1802-6. doi: 10.1016/j.athoracsur.2012.03.022. Epub 2012 May 4.
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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.
Kevin Forton, PhD principal investigator
Erasme University Hospital ULB
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 Exercise Test and Thoracic Cancer, run by Université Libre de Bruxelles at 1 site in Belgium.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Aug 2022. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexis Gillet, Pt, Msc (+3225558386, alexis.gillet@erasme.ulb.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: within 30 days after surgery). The study lists 4 primary outcomes in all. 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 NCT05502263, 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 16 Aug 2022.