Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery

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

Sponsors

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

Source 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.

Overall Status Recruiting
Start Date September 1, 2017
Completion Date December 31, 2021
Primary Completion Date December 31, 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Pulmonary complications Respiratory complications will be assessed from the first 30 post-operative days or from the hospital stay.
Secondary Outcome
Measure Time Frame
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.
Enrollment 400
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Thoracic surgery

Description: Lung resection surgery

Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- none

Gender: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Ivan Cundrle, M.D., Ph.D. Principal Investigator St. Anne's University Hospital Brno
Overall Contact

Last Name: Ivan Cundrle, M.D., Ph.D.

Phone: 00420543183533

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
University Hospital Brno | Brno, Czech Republic, 60200, Czechia Recruiting Kristian Brat, M.D., Ph.D. 00420532232018 [email protected] Kristian Brat, M.D., Ph.D. Principal 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. Sub-Investigator
St. Anne's University Hospital Brno | Brno, Czech Republic, 65691, Czechia Recruiting Ivan Čundrle, M.D., Ph.D. 00420543183533 [email protected] Ivan Cundrle, M.D., Ph.D. Principal 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. Sub-Investigator
Location Countries

Czechia

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: St. Anne's University Hospital Brno, Czech Republic

Investigator Full Name: Ivan Cundrle

Investigator Title: M.D., Ph.D.

Keywords
Has Expanded Access No
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov