Clinical trial NCT03498352: Rest Ventilatory Parameters Predict Morbidity and Mortality in Thoracic Surgery
Official title: Rest Ventilatory Parameters Predict Morbidity and Mortality in Patients Undergoing Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Complication
Cardiovascular Complication
Keywords: cardiopulmonary exercise testing, thoracic surgery
Lead sponsor: St. Anne's University Hospital Brno, Czech Republic
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Pulmonary complications
timeFrame: Respiratory complications will be assessed from the first 30 post-operative days or from the hospital stay.
Secondary outcomes:
measure: Intensive care length of stay
timeFrame: From the first 30 post-operative days or from the hospital stay.
measure: Hospital length of stay
timeFrame: From the first 30 post-operative days or from the hospital stay.
measure: Cardiovascular complications
timeFrame: Cardiovascular complications will be assessed from the first 30 post-operative days or from the hospital stay.
measure: Mortality
timeFrame: 30 and 90 days after surgery.
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
state: Czech Republic
city: Brno
country: Czechia
facility: St. Anne's University Hospital Brno
state: Czech Republic
Study officials:
affiliation: St. Anne's University Hospital Brno
name: Ivan Cundrle, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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