Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02473588
• Other study ID #: 18022
• Status: Recruiting
• Phase: N/A
• First received: June 11, 2015
• Last updated: June 12, 2015
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: University of Virginia
• Contact: Robert H Thiele, M.D.
• Phone: 434-243-9412
• Email: rht7w[@]virginia.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• Retia 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

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pearson Correlation Coefficient	Correlation between change in CO from LTIA vs. change in CO from esophageal Doppler	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	No