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

NCT ID: NCT05502263

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-10-30

Brief 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.

Conditions

Exercise Test; Thoracic Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

moderate/high risk

FEV and/or DLCO \<80% And VO2peak \<20ml/kg.min or \<75% predicted value

No interventions assigned to this group

Control

FEV and DLCO \>80% and VO2peak \> 20ml/kg.min or \>75% predicted value

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université Libre de Bruxelles

OTHER

Sponsor Role: lead

Responsible Party

Kevin Forton

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Forton, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasme University Hospital ULB

Locations

Erasme Hospital

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Alexis Gillet, Pt, Msc

Role: CONTACT

alexis.gillet@erasme.ulb.ac.be

+3225558386

Facility Contacts

Alexis Gillet, Msc

Role: primary

alexis.gillet@erasme.ulb.ac.be

025558386

Forton Kevin, PhD

Role: backup

kevin.forton@ulb.be

025555016

References

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.

Reference Type: BACKGROUND

PMID: 22560968 (View on PubMed)

Other Identifiers

2021293

Identifier Type: -

Identifier Source: org_study_id