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Status unknownNCT02473588Updated Jun 16, 2015

Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

An interventional study of Retia Medical Long Time Interval Analysis in Hypotension, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-16.

Sponsored by University of Virginia · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hypotension

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03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 675 interventional studies indexed under Hypotension.

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Lead sponsor

University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    LTIA Group

    Patients in the LTIA Group (all patients) will have blood pressure recorded continuously. LTIA will be used to measure stroke volume and cardiac output after the completion of data collection

    Device: Retia Medical Long Time Interval Analysis

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

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What researchers measure

Primary outcomes

  1. Pearson Correlation Coefficient

    Correlation between change in CO from LTIA vs. change in CO from esophageal Doppler

    Time frame: Data collected in first 20 minutes of anesthesia/surgery will be recorded; Pearson correlation coefficient will be calculated after all 60 subjects have been enrolled

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Study locations

1 of 1 sites recruiting
  • University of Virginia Health System
    Charlottesville, Virginia 22908, United States
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02473588
Lead sponsor
University of Virginia
Responsible party
Robert Thiele, MD (Assistant Professor, University of Virginia) — Principal investigator
First posted
Jun 16, 2015
Start date
Jun 2015
Primary completion
Nov 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Jun 16, 2015

Study contacts

Robert H Thiele, M.D.
Contact
rht7w@virginia.edu
434-243-9412

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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