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Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

Comparison of Retia Medical (Long Time Interval Analysis) to Deltex Esophageal Doppler for Cardiac Output Measurement

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02473588
Enrollment
60
Registered
2015-06-16
Start date
2015-06-30
Completion date
2015-12-31
Last updated
2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Brief summary

A group of engineers at Michigan State developed a novel waveform analysis technique (Long Time Interval Analysis \[LTIA\]) that attempts to estimate cardiac output non-invasively. Retrospective comparison of LTIA to invasive techniques (e.g. thermodilution) suggest acceptable agreement. Thus, a prospective trial of LTIA is warranted. This study compares LTIA to a validated measure of cardiac output - esophageal Doppler monitoring.

Interventions

DEVICERetia Medical Long Time Interval Analysis

Retia Medical Long Time Interval Analysis will be used to analyze the blood pressure tracing of patients having surgery who have an arterial catheter

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult (18 years or older) * Undergoing hepatobiliary surgery (open or laparoscopic) requiring general anesthesia as part of the patient's clinical care * Attending anesthesiologist plans to place an intra-arterial catheter for routine care * Attending anesthesiologist believes that non-invasive cardiac output monitoring would benefit the patient

Exclusion criteria

* Minors (17 years or younger) * Parturient (pregnant women) * Cognitively impaired * Unable to sign informed consent form * Prisoner * Prior esophageal surgery * Moderate to severe aortic regurgitation * Mechanical cardiac support (e.g., intra-aortic balloon pump) * Severe, persistent arrhythmias

Design outcomes

Primary

MeasureTime frameDescription
Pearson Correlation CoefficientData collected in first 20 minutes of anesthesia/surgery will be recorded; Pearson correlation coefficient will be calculated after all 60 subjects have been enrolledCorrelation between change in CO from LTIA vs. change in CO from esophageal Doppler

Countries

United States

Contacts

Primary ContactRobert H Thiele, M.D.
rht7w@virginia.edu434-243-9412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026