Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery

Completed

• Conditions: Cardiovascular Complication; Pulmonary Complication

• Registration Number: NCT03498352
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2018-04-07
• Study First Submitted QC: 2018-04-07
• Study First Posted: 2018-04-13
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary complications	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

Name	Time	Method
Intensive care length of stay	From the first 30 post-operative days or from the hospital stay.	In all subjects, intensive care unit length of stay will be assessed.
Cardiovascular complications	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
Hospital length of stay	From the first 30 post-operative days or from the hospital stay.	In all subjects, hospital length of stay will be assessed.
Mortality	30 and 90 days after surgery.	In all subjects, 30 and 90 days mortality will be assessed.

Trial Locations

Locations (2)

University Hospital Brno; 🇨🇿 Brno, Czech Republic, Czechia

St. Anne's University Hospital Brno; 🇨🇿 Brno, Czech Republic, Czechia