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

Sponsor

Critical Perfusion Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03799133

Collaborator

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

Enrollment

Location

Arm

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Failure Ventricular Dysfunction Valvular Heart Disease	Device: Florence device	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Eligible patients will be placed the Florence catheter.Eligible patients will be placed the Florence catheter.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Sep 26, 2018

Actual Primary Completion Date :

Dec 28, 2019

Actual Study Completion Date :

Dec 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with Florence device Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend.	Device: Florence device The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU. Other Names: ISMO Gastric Impedance Spectrometer System

Arm

Intervention/Treatment

Experimental: Patients with Florence device

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

Device: Florence device

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

Other Names:

ISMO

Gastric Impedance Spectrometer System

Outcome Measures

Primary Outcome Measures

Correlation between gastric reactance (XL) and morbimortality and risk predictors [72 hours]
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 [72 hours]
ROC curves will be calculated to determine sensibility and specificity of the variables.
Adverse events tracing with the use of Florence catheter [30 days]
Serious Adverse Device Effects and Adverse Events assessment to evaluate device safety.

Secondary Outcome Measures

Correlations between XL measurements and medication [72 hours]
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 [72 hours]
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. [72 hours]
Questionnaire for the nurse and/or the physician regarding the use of Florence device at the Operating Room and Intensive Care Unit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Nacional de Cardiología Ignacio Chávez	Tlalpan	Ciudad De México	Mexico	14080

Sponsors and Collaborators

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

Investigators

Principal Investigator: Rolando J. Álvarez Álvarez, MD, Instituto Nacional de Cardiologia Ignacio Chavez
Study Director: Montserrat Godínez, MSc, Alandra Medical SAPI de CV