Calibrating Cardiac Output Measurement of Electrical Cardiometry With Transthoracic Echocardiography
EC vs TTE
1 other identifier
interventional
75
1 country
1
Brief Summary
Cardiac output (CO) is a key variable when describing the cardiovascular system. Electrical cardiometry (EC) is a non-invasive method in measuring stroke volume and cardiac output. However, its accuracy has been inconsistent. Therefore Martin et al. have compared measurements with echocardiographic measurements and propose calibration with left ventricle outflow tract (LVOT)-measurements obtained from transthoracic echocardiography (TTE). This study was performed in pregnant women at term. Goal of this study is to validate their formula in non-pregnant outpatients undergoing echocardiography for cardiology work-up. Secondary aim is to perform a leg raising test and to compare changes in stroke volume observed with either EC or TTE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Oct 2015
Shorter than P25 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 26, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 8, 2016
March 1, 2016
6 months
February 26, 2016
March 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
agreement Stroke volume
SV measured by TTE, RHC and EC will be compared
3 seconds
Study Arms (3)
TTE vs. EC + calibration group
OTHER50 Patients undergoing routine transthoracic echocardiography at laboratory for transthoracic echocardiography at the department of cardiology of Medical University Vienna will be enrolled following informed consent. Non-inclusion criteria are inability to understand study procedure and age under 18 years old. Patients with any grade of aortic regurgitation, congenital heart disease with intracardiac shunt (left-right shunt or right-left shunt) or arrhythmia (atrial fibrillation) or withdrawing consent during study procedure will be excluded. In addition, patients with intraabdominal (IAH), intracranial (ICH) hypertension or any disease of the hip joint, will not be included into the trial.
Right heart catheterisation
OTHERTwenty five patients undergoing routine right heart catheterization (RHC) at the department of cardiology for the evaluation of suspected pulmonary hypertension or heart failure will be included in this trial. EC measurements will be obtained during RHC, and a TTE (for measuring LVOT-area) will be performed immediately before undergoing RHC. Inclusion and exclusion criteria are similar as described above.
Passive leg raising test
OTHER50 Patients undergoing routine transthoracic echocardiography at laboratory for transthoracic echocardiography at the department of cardiology of Medical University Vienna will be enrolled following informed consent. Non-inclusion criteria are inability to understand study procedure and age under 18 years old. Patients with any grade of aortic regurgitation, congenital heart disease with intracardiac shunt (left-right shunt or right-left shunt) or arrhythmia (atrial fibrillation) or withdrawing consent during study procedure will be excluded. In addition, patients with intraabdominal (IAH), intracranial (ICH) hypertension or any disease of the hip joint, will not be included into the trial. SV and CO will be measured using TTE and EC. Patient's legs will then be raised by 45degree, and SV and CO measurements will be repeated after 1 minute. Changes in SV and CO observed with both methods will be compared.
Interventions
CO in patients undergoing routine right heart catheterisation will be measured and compared between 3 methodologies: right heart catheterisation, TTE and EC
Patients undergoing routine echocardiography are exposed to a passive leg raising test. Change in SV will be measured by TTE and compared to changes in SV measured by EC.
Patients will undergo routine echocardiography. CO and SV will be measured by TTE and compared to measurements obtained from simultaneous EC-measurements.
Eligibility Criteria
You may qualify if:
- age above 18 years
- able to understand study procedure
You may not qualify if:
- aortic regurgitation
- congenital heart disease with intracardiac shunt
- arrhythmia
- withdrawing consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Viennalead
- University of California, San Diegocollaborator
Study Sites (1)
Medical University Vienna
Vienna, Vienna, 1080, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 26, 2016
First Posted
March 8, 2016
Study Start
October 1, 2015
Primary Completion
April 1, 2016
Study Completion
December 1, 2016
Last Updated
March 8, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share