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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Anne's University Hospital Brno, Czech Republic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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