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| ID | Type | Description | Link |
|---|---|---|---|
| 17-1025 | Other Identifier | Instituto Nacional de Cardiología Ignacio Chávez |
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| Name | Class |
|---|---|
| Instituto Nacional de Cardiologia Ignacio Chavez | OTHER |
| National Council of Science and Technology, Mexico | OTHER |
| Gerbera Capital | OTHER |
| Alandra Medical SAPI de CV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Florence device | Experimental | Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florence device | Device | The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 72 hours |
| Sensibility and specificity of the collected variables | ROC curves will be calculated to determine sensibility and specificity of the variables. | 72 hours |
| Adverse events tracing with the use of Florence catheter | Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
| Correlations between laboratory parameters and XL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolando J. Álvarez Álvarez, MD | Instituto Nacional de Cardiologia Ignacio Chavez | Principal Investigator |
| Montserrat Godínez, MSc | Alandra Medical SAPI de CV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Cardiología Ignacio Chávez | Tlalpan | Mexico City | 14080 | Mexico |
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| Label | URL |
|---|---|
| WHO Cardiovascular illness; 2015 | View source |
| Arias AS, Serrano MEB, Altamirano BD, Ortega MG, Gonzalez GG. Cardiovascular illness: first cause of morbility in a third level hospital. Cardiology Mexican Journal; 2016 | View source |
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There is no plan to make individual participant data (IPD) available to other researchers.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018754 | Ventricular Dysfunction |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| INDUSTRY |
Eligible patients will be placed the Florence catheter.
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Multivariate analysis to observe variability between different events according to data distribution to determine how is affecting XL with laboratory parameters. |
| 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. | 72 hours |
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