Safety and Efficacy of the Gastric Reactance (XL) in Patients Post-operated of Elective Cardiac Surgery
NCT ID: NCT03799133
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2018-09-26
2019-12-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Patients with Florence device
Patients with the Florence catheter placed and connected to the Florence monitor to measure XL trend.
Florence device
The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
Interventions
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Florence device
The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Instituto Nacional de Cardiologia Ignacio Chavez
OTHER
National Council of Science and Technology, Mexico
OTHER
Gerbera Capital
OTHER
Alandra Medical SAPI de CV
INDUSTRY
Critical Perfusion Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rolando J. Álvarez Álvarez, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cardiologia Ignacio Chavez
Montserrat Godínez, MSc
Role: STUDY_DIRECTOR
Alandra Medical SAPI de CV
Locations
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Instituto Nacional de Cardiología Ignacio Chávez
Tlalpan, Mexico City, Mexico
Countries
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Related Links
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Other Identifiers
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17-1025
Identifier Type: OTHER
Identifier Source: secondary_id
ISM_VC_01_17
Identifier Type: -
Identifier Source: org_study_id
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