Evaluate the safety and effectiveness of the XL trend measured by Florence (Critical Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients post-operated of elective cardiovascular surgery. Hypothesis: 1. The gastric reactance measurement (XL) correlates with the morbimortality (postoperatory shock, excessive bleeding, vasoplegic syndrome and death) and with the risk predictors (APACHE II, STS, SOFA, and EUROSCORE II) with patients post-operated of elective cardiac surgery. 2. It is possible to identify the cut-off point of the values of the gastric reactance (XL) as a predictive tool of morbimortality in patients post-operated of elective cardiac surgery. 3. The gastric reactance (XL) is a safe measurement to patients undergoing cardiac surgery.
A maximum of 35 patients with age greater or equal to 18 years with elective surgery (valvular surgery, revascularization, or a combination of both) that comply with the inclusion/exclusion criteria of this protocol will be enrolled. Investigational device: Florence (Gastric Impedance Spectrometer System or ISMO). Comparative with Risk scales SOFA, APACHE II, STS, Euroscore II, hemodynamic variables, lactate and mixed venous saturation. The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
38
The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
Instituto Nacional de Cardiología Ignacio Chávez
Tlalpan, Mexico City, Mexico
Correlation between gastric reactance (XL) and morbimortality and risk predictors
Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting the risk scales, hemodynamic variables, lactate and mixed venous oxygen saturation, morbidity and mortality with central gastric reactance (XL).
Time frame: 72 hours
Sensibility and specificity of the collected variables
ROC curves will be calculated to determine sensibility and specificity of the variables.
Time frame: 72 hours
Adverse events tracing with the use of Florence catheter
Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.
Time frame: 30 days
Correlations between XL measurements and medication
Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with amines, proton-pump inhibitors, and anesthesia medications.
Time frame: 72 hours
Correlations between laboratory parameters and XL
Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with laboratory parameters.
Time frame: 72 hours
Usability of Florence device in a real environment.
Questionnaire for the nurse and/or the physician regarding the use of Florence device at the Operating Room and Intensive Care Unit.
Time frame: 72 hours
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