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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Shorter than P25 for not_applicable
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
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 16, 2015
June 1, 2015
5 months
June 11, 2015
June 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
LTIA Group
OTHERPatients 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
Interventions
Retia Medical "Long Time Interval Analysis" will be used to analyze the blood pressure tracing of patients having surgery who have an arterial catheter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 16, 2015
Study Start
June 1, 2015
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
June 16, 2015
Record last verified: 2015-06