Interest of CPET to Predict Mortality and Complications of Lung Resection Candidates

Thoracic Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502263
• Other study ID #: 2021293
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: August 2022
• Source: Université Libre de Bruxelles
• Contact: Alexis Gillet, Pt, Msc
• Phone: +3225558386
• Email: alexis.gillet[@]erasme.ulb.ac.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Lobectomy or Segmentectomy or Wedge Resection for Non-Small Cell Lung cancer

• Performed CPET

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Exercise Test
• Thoracic Cancer

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Brunelli A, Belardinelli R, Pompili C, Xiumé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	death	within 30 days after surgery
Primary	Mortality	death	within 12 months after surgery
Primary	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	within 30 days after surgery
Primary	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	within 30 days after surgery