Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT02473588

Conditions

Hypotension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Retia Medical Long Time Interval Analysis

Study Details

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.

Conditions

Hypotension

Study ID

NCT02473588

Start date

Jun, 2015

Status verified date

Jun, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Nov, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: LTIA Group

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

Interventions

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

Primary outcome measure

  • Pearson Correlation Coefficient [ 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 ]

Central Contacts and Locations

Central contacts

Robert H Thiele, M.D.

434-243-9412rht7w@virginia.edu

Locations

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Robert H Thiele, M.D.

434-243-9412rht7w@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Jun 16, 2015

Last verified

Jun, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2015-06-16.