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Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT03498352
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic

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.

Condition or disease Intervention/treatment
Pulmonary Complication Cardiovascular Complication Procedure: Thoracic surgery

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rest Ventilatory Parameters Predict Morbidity and Mortality in Patients Undergoing Thoracic Surgery
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Intervention Details:
  • Procedure: Thoracic surgery
    Lung resection surgery


Primary Outcome Measures :
  1. Pulmonary complications [ Time Frame: Respiratory complications will be assessed from the first 30 post-operative days or from the hospital stay. ]
    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


Secondary Outcome Measures :
  1. Intensive care length of stay [ Time Frame: From the first 30 post-operative days or from the hospital stay. ]
    In all subjects, intensive care unit length of stay will be assessed.

  2. Hospital length of stay [ Time Frame: From the first 30 post-operative days or from the hospital stay. ]
    In all subjects, hospital length of stay will be assessed.

  3. Cardiovascular complications [ Time Frame: Cardiovascular complications will be assessed from the first 30 post-operative days or from the hospital stay. ]
    Cardiovascular complications definition: new arrhythmias (atrial fibrillation, supraventricular tachycardia, etc.); hypotension; heart failure; pulmonary edema; pulmonary embolism; myocardial infarction/minimal myocardial lesion; cardiopulmonary resuscitation

  4. Mortality [ Time Frame: 30 and 90 days after surgery. ]
    In all subjects, 30 and 90 days mortality will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498352


Contacts
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Contact: Ivan Cundrle, M.D., Ph.D. 00420543183533 Ivan.Cundrle@fnusa.cz
Contact: Kristian Brat, M.D., Ph.D. 00420532232018 Brat.Kristian@fnbrno.cz

Locations
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Czechia
University Hospital Brno Recruiting
Brno, Czech Republic, Czechia, 60200
Contact: Kristian Brat, M.D., Ph.D.    00420532232018    Brat.kristian@fnbrno.cz   
Contact: Zdenek Merta, M.D., Ph.D.    00420532232409    Merta.Zdenek@fnbrno.cz   
Principal Investigator: Kristian Brat, M.D., Ph.D.         
Sub-Investigator: Zdenek Merta, M.D., Ph.D.         
Sub-Investigator: Jana Skrickova, M.D., Ph.D.         
Sub-Investigator: Michaela Parezova, M.D.         
Sub-Investigator: Jaroslav Ivicic, M.D.         
Sub-Investigator: Teodor Horvath, M.D., Ph.D.         
St. Anne's University Hospital Brno Recruiting
Brno, Czech Republic, Czechia, 65691
Contact: Ivan Čundrle, M.D., Ph.D.    00420543183533    Ivan.Cundrle@fnusa.cz   
Contact: Milos Chobola, M.D.    00420543183533    Milos.Chobola@fnusa.cz   
Principal Investigator: Ivan Cundrle, M.D., Ph.D.         
Sub-Investigator: Milos Chobola, M.D.         
Sub-Investigator: Zdenek Chovanec, M.D., Ph.D.         
Sub-Investigator: Michal Benej, M.D., Ph.D.         
Sub-Investigator: Vladimir Sramek, M.D., Ph.D.         
Sub-Investigator: Pavel Homolka, M.D., Ph.D.         
Sponsors and Collaborators
St. Anne's University Hospital Brno, Czech Republic
Investigators
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Principal Investigator: Ivan Cundrle, M.D., Ph.D. St. Anne's University Hospital Brno

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ivan Cundrle, M.D., Ph.D., St. Anne's University Hospital Brno, Czech Republic
ClinicalTrials.gov Identifier: NCT03498352    
Other Study ID Numbers: IIT/2017/12 and 2018/08
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic:
cardiopulmonary exercise testing, thoracic surgery