Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

Not Applicable

• Conditions: Hypotension
• Interventions: Device: Retia Medical Long Time Interval Analysis

• Registration Number: NCT02473588
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2015-06
• Study Start: 2015-06
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-06-12
• Last Update Submitted: 2015-06-12
• Study First Posted: 2015-06-16
• Last Update Posted: 2015-06-16
• Primary Completion: 2015-11
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LTIA Group	Retia Medical Long Time Interval Analysis	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States