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Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery

Primary Purpose

Cardiac Failure, Ventricular Dysfunction, Valvular Heart Disease

Status

Completed

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Florence device

About this trial

This is an interventional screening trial for Cardiac Failure focused on measuring gastric reactance, elective cardiac surgery, morbimortality, APACHE II, STS, SOFA, EUROSCORE II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Women and men within an age equal or greater than 18 years old.
Subjects scheduled to an elective cardiac surgery for valvular surgery, revascularization or a combination of both.
Subjects compliant with the indication to be placed a floating pulmonary artery catheter.
Marks results previous to surgery: STS mortality risk equal or greater than 6% of the day before or Euro Score II with a mortality risk equal or greater than 6% or left ventricle ejection fraction (LVEF/FEVI) less than 45% (patients with cardiac failure or right ventricle dysfunction or a combination of both), tricuspid annular plane systolic excursion (TAPSE) less than 17 mm, peak systolic velocity of tricuspid lateral ring measured by Tissue Doppler (LVOT/TSVI) less than 0.1 m/s; patient with elective surgery of: aortic and mitral valve replacement or aortic and mitral valve replacement + tricuspid valve plasty or aortic valve replacement + mitral valve plasty or mitral valve replacement + tricuspid valve plasty or aortic, mitral and tricuspid valve replacement or aortic valve replacement + tricuspid valve plasty or double valve replacement (any combination) + revascularization or aortic valve replacement + revascularization + mitral valve plasty.
Subject is not enrolled in another investigational protocol.
Informed consent has been signed of acceptance by the subject before study procedures.
Subject in sinus rhythm before surgery.

Exclusion Criteria:

Subjects with records of recent digestive tube bleeding (last 30 days).
Paraplegic or hemiplegic subjects.
Subjects with congenital background (interauricular communication, ventricular atrial channel, coarctation of the aorta, persistent arterial duct, pulmonary stenosis, ventricular septal defect, tetralogy of fallot, total or partial anomalous pulmonary venous drainage, transposition of the great vessels, tricuspid atresia, arterial trunk, etc).
Maxillofacial malformation.
Catheter placement failure.
Known pregnancy or discovered pregnancy after admission (before surgery).
Woman in breastfeeding period.
Subjects not compliant with clinical indication of nasogastric catheter placement or contraindicated to place a nasogastric catheter.
Subjects with an implanted pacemaker or permanent defibrillator.
Medication supply that impedes contact between Florence catheter and the gastric mucosa (barrier effect) like sucralfate, aluminum hydroxide, bismuth subsalicylate, magaldrate, etc.

Sites / Locations

Instituto Nacional de Cardiología Ignacio Chávez

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Florence device

Arm Description

Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend.

Outcomes

Primary Outcome Measures

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).

Sensibility and specificity of the collected variables

ROC curves will be calculated to determine sensibility and specificity of the variables.

Adverse events tracing with the use of Florence catheter

Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT03799133

First Posted

December 20, 2018

Last Updated

January 22, 2020

Sponsor

Critical Perfusion Inc.

Collaborators

Instituto Nacional de Cardiologia Ignacio Chavez, National Council of Science and Technology, Mexico, Gerbera Capital, Alandra Medical SAPI de CV

1. Study Identification

Unique Protocol Identification Number

NCT03799133

Brief Title

Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery

Official Title

Safety and Efficacy of the Gastric Reactance (XL) in the Prediction of Morbimortality in Patients Post-operated of Elective Cardiac Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

September 26, 2018 (Actual)

Primary Completion Date

December 28, 2019 (Actual)

Study Completion Date

December 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Critical Perfusion Inc.

Collaborators

Instituto Nacional de Cardiologia Ignacio Chavez, National Council of Science and Technology, Mexico, Gerbera Capital, Alandra Medical SAPI de CV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Failure, Ventricular Dysfunction, Valvular Heart Disease

Keywords

gastric reactance, elective cardiac surgery, morbimortality, APACHE II, STS, SOFA, EUROSCORE II

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Eligible patients will be placed the Florence catheter.

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with Florence device

Arm Type

Experimental

Arm Description

Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend.

Intervention Type

Device

Intervention Name(s)

Florence device

Other Intervention Name(s)

ISMO, Gastric Impedance Spectrometer System

Intervention Description

The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.

Primary Outcome Measure Information:

Title

Correlation between gastric reactance (XL) and morbimortality and risk predictors

Description

Time Frame

72 hours

Title

Sensibility and specificity of the collected variables

Description

ROC curves will be calculated to determine sensibility and specificity of the variables.

Time Frame

72 hours

Title

Adverse events tracing with the use of Florence catheter

Description

Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Correlations between XL measurements and medication

Description

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

Title

Correlations between laboratory parameters and XL

Description

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

Title

Usability of Florence device in a real environment.

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women and men within an age equal or greater than 18 years old. Subjects scheduled to an elective cardiac surgery for valvular surgery, revascularization or a combination of both. Subjects compliant with the indication to be placed a floating pulmonary artery catheter. Marks results previous to surgery: STS mortality risk equal or greater than 6% of the day before or Euro Score II with a mortality risk equal or greater than 6% or left ventricle ejection fraction (LVEF/FEVI) less than 45% (patients with cardiac failure or right ventricle dysfunction or a combination of both), tricuspid annular plane systolic excursion (TAPSE) less than 17 mm, peak systolic velocity of tricuspid lateral ring measured by Tissue Doppler (LVOT/TSVI) less than 0.1 m/s; patient with elective surgery of: aortic and mitral valve replacement or aortic and mitral valve replacement + tricuspid valve plasty or aortic valve replacement + mitral valve plasty or mitral valve replacement + tricuspid valve plasty or aortic, mitral and tricuspid valve replacement or aortic valve replacement + tricuspid valve plasty or double valve replacement (any combination) + revascularization or aortic valve replacement + revascularization + mitral valve plasty. Subject is not enrolled in another investigational protocol. Informed consent has been signed of acceptance by the subject before study procedures. Subject in sinus rhythm before surgery. Exclusion Criteria: Subjects with records of recent digestive tube bleeding (last 30 days). Paraplegic or hemiplegic subjects. Subjects with congenital background (interauricular communication, ventricular atrial channel, coarctation of the aorta, persistent arterial duct, pulmonary stenosis, ventricular septal defect, tetralogy of fallot, total or partial anomalous pulmonary venous drainage, transposition of the great vessels, tricuspid atresia, arterial trunk, etc). Maxillofacial malformation. Catheter placement failure. Known pregnancy or discovered pregnancy after admission (before surgery). Woman in breastfeeding period. Subjects not compliant with clinical indication of nasogastric catheter placement or contraindicated to place a nasogastric catheter. Subjects with an implanted pacemaker or permanent defibrillator. Medication supply that impedes contact between Florence catheter and the gastric mucosa (barrier effect) like sucralfate, aluminum hydroxide, bismuth subsalicylate, magaldrate, etc.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rolando J. Álvarez Álvarez, MD

Organizational Affiliation

Instituto Nacional de Cardiologia Ignacio Chavez

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Montserrat Godínez, MSc

Organizational Affiliation

Alandra Medical SAPI de CV

Official's Role

Study Director

Facility Information:

Facility Name

Instituto Nacional de Cardiología Ignacio Chávez

City

Tlalpan

State/Province

Ciudad De México

ZIP/Postal Code

14080

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

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Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery

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