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OpenTrials
Completed

NCT Number: NCT03498352

Rest Ventilatory Parameters Predict Morbidity and Mortality in 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.

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Key information

Conditions

Pulmonary Complication Cardiovascular Complication

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

thoracic surgery

Procedure

Lung resection surgery

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

St. Anne's University Hospital Brno, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2018
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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