Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery

NCT03498352 | Completed

• 1 other identifier: IIT/2017/12 and 2018/08
• Study Type: observational
• Target: 366
• Locations: 1 country
• Sites: 2

Brief Summary

Cardiopulmonary exercise testing is recommended for preoperative evaluation and risk stratification of lung resection candidates. Ventilatory efficiency (VE/VCO2 slope) has been shown to predict morbidity and mortality in lung resection candidates and has been shown superior to peak oxygen consumption (VO2). Patients with increased VE/VCO2 during exercise also exhibit increased VE/VCO2 ratio and decreased end-tidal CO2 at rest. Our first hypothesis is that rest ventilatory parameters predict morbidity and mortality in patients undergoing thoracic surgery. VE/VCO2 is well correlated with ventilation-perfusion mismatch, therefore it may be useful in hypoxemia prediction during one-lung ventilation during thoracic surgery. Our second hypothesis is that patients with high VE/VCO2 will be prone to hypoxemia development during one-lung ventilation.

Conditions

Pulmonary Complication; Cardiovascular Complication

Keywords

cardiopulmonary exercise testing, thoracic surgery

Outcome Measures

Primary Outcomes (1)

• Pulmonary complications

  Respiratory complications definition: pneumonia, atelectasis; respiratory failure needing mechanical ventilation; adult respiratory distress syndrome; pneumothorax present on the 3rd post-operative day; long-lasting pleural effusions present on the 3rd post-operative day

  Respiratory complications will be assessed from the first 30 post-operative days or from the hospital stay.

Secondary Outcomes (4)

• Intensive care length of stay

  From the first 30 post-operative days or from the hospital stay.

• Hospital length of stay

  From the first 30 post-operative days or from the hospital stay.

• Cardiovascular complications

  Cardiovascular complications will be assessed from the first 30 post-operative days or from the hospital stay.

• Mortality

  30 and 90 days after surgery.

Interventions

Thoracic surgery PROCEDURE

Lung resection surgery

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients planned for thoracotomy because of lung infiltration (confirmed or highly suspicious lung tumor). Patients will be recruited from 2 centers in the Czech Republic (St. Anne's University Hospital, Brno, Czech Republic and University Hospital in Brno).

You may qualify if:

• thoracotomy because of lung infiltration (confirmed or highly suspicious lung tumor)

You may not qualify if:

• none

Sponsors & Collaborators

• St. Anne's University Hospital Brno, Czech Republic: lead

Study Sites (2)

University Hospital Brno

Brno, Czech Republic, 60200, Czechia

Location

St. Anne's University Hospital Brno

Brno, Czech Republic, 65691, Czechia

Location

Related Publications (18)

• 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.

  PMID: 22560968 BACKGROUND

• Choi H, Mazzone P. Preoperative evaluation of the patient with lung cancer being considered for lung resection. Curr Opin Anaesthesiol. 2015 Feb;28(1):18-25. doi: 10.1097/ACO.0000000000000149.

  PMID: 25486485 BACKGROUND

• Brunelli A, Charloux A, Bolliger CT, Rocco G, Sculier JP, Varela G, Licker M, Ferguson MK, Faivre-Finn C, Huber RM, Clini EM, Win T, De Ruysscher D, Goldman L; European Respiratory Society and European Society of Thoracic Surgeons joint task force on fitness for radical therapy. ERS/ESTS clinical guidelines on fitness for radical therapy in lung cancer patients (surgery and chemo-radiotherapy). Eur Respir J. 2009 Jul;34(1):17-41. doi: 10.1183/09031936.00184308.

  PMID: 19567600 BACKGROUND

• Arena R, Myers J, Aslam SS, Varughese EB, Peberdy MA. Peak VO2 and VE/VCO2 slope in patients with heart failure: a prognostic comparison. Am Heart J. 2004 Feb;147(2):354-60. doi: 10.1016/j.ahj.2003.07.014.

  PMID: 14760336 BACKGROUND

• Cundrle I Jr, Johnson BD, Rea RF, Scott CG, Somers VK, Olson LJ. Modulation of ventilatory reflex control by cardiac resynchronization therapy. J Card Fail. 2015 May;21(5):367-373. doi: 10.1016/j.cardfail.2014.12.013. Epub 2015 Jan 8.

  PMID: 25576681 BACKGROUND

• Cundrle I Jr, Somers VK, Johnson BD, Scott CG, Olson LJ. Exercise end-tidal CO2 predicts central sleep apnea in patients with heart failure. Chest. 2015 Jun;147(6):1566-1573. doi: 10.1378/chest.14-2114.

  PMID: 25742609 BACKGROUND

• Guenoun T, Journois D, Silleran-Chassany J, Frappier J, D'attellis N, Salem A, Safran D. Prediction of arterial oxygen tension during one-lung ventilation: analysis of preoperative and intraoperative variables. J Cardiothorac Vasc Anesth. 2002 Apr;16(2):199-203. doi: 10.1053/jcan.2002.31067.

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  PMID: 8268428 BACKGROUND

• Schwarzkopf K, Klein U, Schreiber T, Preussetaler NP, Bloos F, Helfritsch H, Sauer F, Karzai W. Oxygenation during one-lung ventilation: the effects of inhaled nitric oxide and increasing levels of inspired fraction of oxygen. Anesth Analg. 2001 Apr;92(4):842-7. doi: 10.1097/00000539-200104000-00009.

  PMID: 11273912 BACKGROUND

• Slinger P, Suissa S, Triolet W. Predicting arterial oxygenation during one-lung anaesthesia. Can J Anaesth. 1992 Dec;39(10):1030-5. doi: 10.1007/BF03008370.

  PMID: 1464128 BACKGROUND

• Slinger P, Triolet W, Wilson J. Improving arterial oxygenation during one-lung ventilation. Anesthesiology. 1988 Feb;68(2):291-5. doi: 10.1097/00000542-198802000-00022. No abstract available.

  PMID: 3277487 BACKGROUND

• Katz Y, Zisman E, Isserles SA, Rozenberg B. Left, but not right, one-lung ventilation causes hypoxemia during endoscopic transthoracic sympathectomy. J Cardiothorac Vasc Anesth. 1996 Feb;10(2):207-9. doi: 10.1016/s1053-0770(96)80238-2.

  PMID: 8850398 BACKGROUND

• Yokota K, Toriumi T, Sari A, Endou S, Mihira M. Auto-positive end-expiratory pressure during one-lung ventilation using a double-lumen endobronchial tube. Anesth Analg. 1996 May;82(5):1007-10. doi: 10.1097/00000539-199605000-00021.

  PMID: 8610857 BACKGROUND

• Karzai W, Schwarzkopf K. Hypoxemia during one-lung ventilation: prediction, prevention, and treatment. Anesthesiology. 2009 Jun;110(6):1402-11. doi: 10.1097/ALN.0b013e31819fb15d.

  PMID: 19417615 BACKGROUND

• Nomoto Y. Preoperative pulmonary blood flow and one-lung anaesthesia. Can J Anaesth. 1987 Sep;34(5):447-9. doi: 10.1007/BF03014346.

  PMID: 3664910 BACKGROUND

• Woods PR, Olson TP, Frantz RP, Johnson BD. Causes of breathing inefficiency during exercise in heart failure. J Card Fail. 2010 Oct;16(10):835-42. doi: 10.1016/j.cardfail.2010.05.003. Epub 2010 Jun 16.

  PMID: 20932466 BACKGROUND

• Filakovszky A, Brat K, Tschoellitsch T, Bartos S, Mazur A, Meier J, Olson L, Cundrle I. Cardiopulmonary exercise testing before lung resection surgery: still indicated? Evaluating predictive utility using machine learning. Thorax. 2025 Oct 2:thorax-2024-221485. doi: 10.1136/thorax-2024-221485. Online ahead of print.

  PMID: 41043965 DERIVED

• Brat K, Chobola M, Homolka P, Heroutova M, Benej M, Mitas L, Olson LJ, Cundrle I. Poor ventilatory efficiency during exercise may predict prolonged air leak after pulmonary lobectomy. Interact Cardiovasc Thorac Surg. 2020 Feb 1;30(2):269-272. doi: 10.1093/icvts/ivz255.

  PMID: 31630177 DERIVED

MeSH Terms

Interventions

Thoracic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Ivan Cundrle, M.D., Ph.D.

  St. Anne's University Hospital Brno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 13, 2018
• Study Start: May 1, 2017
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)