Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery

Cardiovascular Complication Clinical Trial

Official title:

Rest Ventilatory Parameters Predict Morbidity and Mortality in Patients Undergoing Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498352
• Other study ID #: IIT/2017/12 and 2018/08
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2021
• Source: St. Anne's University Hospital Brno, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Cardiovascular Complication
• Pulmonary Complication

Intervention

Procedure:
• Thoracic surgery
Lung resection surgery

Locations

Country	Name	City	State
Czechia	St. Anne's University Hospital Brno	Brno	Czech Republic
Czechia	University Hospital Brno	Brno	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
St. Anne's University Hospital Brno, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (16)

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. — View Citation

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

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. Erratum in: Eur Respir J. 2009 Sep;34(3):782. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hurford WE, Alfille PH. A quality improvement study of the placement and complications of double-lumen endobronchial tubes. J Cardiothorac Vasc Anesth. 1993 Oct;7(5):517-20. — View Citation

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. Review. — View Citation

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. — View Citation

Nomoto Y. Preoperative pulmonary blood flow and one-lung anaesthesia. Can J Anaesth. 1987 Sep;34(5):447-9. — View Citation

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. — View Citation

Slinger P, Suissa S, Triolet W. Predicting arterial oxygenation during one-lung anaesthesia. Can J Anaesth. 1992 Dec;39(10):1030-5. — View Citation

Slinger P, Triolet W, Wilson J. Improving arterial oxygenation during one-lung ventilation. Anesthesiology. 1988 Feb;68(2):291-5. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intensive care length of stay	In all subjects, intensive care unit length of stay will be assessed.	From the first 30 post-operative days or from the hospital stay.
Secondary	Hospital length of stay	In all subjects, hospital length of stay will be assessed.	From the first 30 post-operative days or from the hospital stay.
Secondary	Cardiovascular complications	Cardiovascular complications definition: new arrhythmias (atrial fibrillation, supraventricular tachycardia, etc.); hypotension; heart failure; pulmonary edema; pulmonary embolism; myocardial infarction/minimal myocardial lesion; cardiopulmonary resuscitation	Cardiovascular complications will be assessed from the first 30 post-operative days or from the hospital stay.
Secondary	Mortality	In all subjects, 30 and 90 days mortality will be assessed.	30 and 90 days after surgery.