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

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Cancer; Exercise Test

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Alexis Gillet, Pt, Msc; Phone Number: +3225558386; Email: alexis.gillet@erasme.ulb.ac.be

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Erasme hospital
    • Contact: Alexis Gillet, Msc; Phone Number: 025558386; Email: alexis.gillet@erasme.ulb.ac.be
    • Contact: Forton Kevin, PhD; Phone Number: 025555016; Email: kevin.forton@ulb.be

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: Probability Sample

Study Population

Lobectomy or Segmentectomy or Wedge Resection for a patient Non-Small Cell Lung cancer patient

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	death	within 30 days after surgery
Mortality	death	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	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	within 30 days after surgery

Collaborators and Investigators

• Sponsor: Université Libre de Bruxelles
• Investigators: Principal Investigator: Kevin Forton, PhD, Erasme University Hospital ULB

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021293

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No