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

January 22, 2020 updated by: Critical Perfusion Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Ciudad De México
      • Tlalpan, Ciudad De México, Mexico, 14080
        • Instituto Nacional de Cardiologia Ignacio Chavez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between XL measurements and medication
Time Frame: 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.
72 hours
Correlations between laboratory parameters and XL
Time Frame: 72 hours
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.
Time Frame: 72 hours
Questionnaire for the nurse and/or the physician regarding the use of Florence device at the Operating Room and Intensive Care Unit.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Critical Perfusion Inc.

Collaborators

National Council of Science and Technology, Mexico
Instituto Nacional de Cardiologia Ignacio Chavez
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2018

Primary Completion (Actual)

December 28, 2019

Study Completion (Actual)

December 28, 2019

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISM_VC_01_17
  • 17-1025 (Other Identifier: Instituto Nacional de Cardiología Ignacio Chávez)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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