Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery

February 9, 2021 updated by: Ivan Cundrle, St. Anne's University Hospital Brno, Czech Republic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

366

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Brno, Czech Republic, Czechia, 60200
        • University Hospital Brno
      • Brno, Czech Republic, Czechia, 65691
        • St. Anne's University Hospital Brno

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Respiratory complications will be assessed from the first 30 post-operative days or from the hospital stay.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the first 30 post-operative days or from the hospital stay.
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.
From the first 30 post-operative days or from the hospital stay.
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
Cardiovascular complications will be assessed from the first 30 post-operative days or from the hospital stay.
Mortality
Time Frame: 30 and 90 days after surgery.
In all subjects, 30 and 90 days mortality will be assessed.
30 and 90 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Anne's University Hospital Brno, Czech Republic

Investigators

  • Principal Investigator: Ivan Cundrle, M.D., Ph.D., St. Anne's University Hospital Brno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

April 7, 2018

First Submitted That Met QC Criteria

April 7, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIT/2017/12 and 2018/08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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