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Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

Primary Purpose

Hypotension

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retia Medical Long Time Interval Analysis
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypotension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LTIA Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 11, 2015
Last Updated
June 12, 2015
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02473588
Brief Title
Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output
Official Title
Comparison of Retia Medical (Long Time Interval Analysis) to Deltex Esophageal Doppler for Cardiac Output Measurement
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LTIA Group
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Retia Medical Long Time Interval Analysis
Intervention Description
Retia Medical "Long Time Interval Analysis" will be used to analyze the blood pressure tracing of patients having surgery who have an arterial catheter
Primary Outcome Measure Information:
Title
Pearson Correlation Coefficient
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert H Thiele, M.D.
Phone
434-243-9412
Email
rht7w@virginia.edu
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert H Thiele, M.D.
Phone
434-243-9412
Email
rht7w@virginia.edu

12. IPD Sharing Statement

Learn more about this trial

Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

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