Long Time Interval Analysis for Non Invasive Measurement of Cardiac Output

NCT ID: NCT02473588

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypotension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

Retia Medical Long Time Interval Analysis

Intervention Type DEVICE

Retia Medical "Long Time Interval Analysis" will be used to analyze the blood pressure tracing of patients having surgery who have an arterial catheter

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robert Thiele, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Virginia Health System

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Robert H Thiele, M.D.

Role: CONTACT

434-243-9412

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Robert H Thiele, M.D.

Role: primary

434-243-9412

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.