Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

University of Virginia

Status: Unknown

Conditions: Hypotension

Treatments: Device: Retia Medical Long Time Interval Analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT02473588

18022

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

LTIA Group

Other group

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

Treatment:

Device: Retia Medical Long Time Interval Analysis