Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire

August 6, 2021 updated by: Respirix, Inc.
This study is designed as an observational study to collect Cardiospire cardiogenic oscillation signal (COS) and CO output parameters from the Pulmonary Artery Catheter in intubated patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Respirix has developed a non-invasive hemodynamic monitoring device called the Cardiospire. The Cardiospire detects minor, cyclic waveforms caused by Cardiogenic Oscillations (COS) and uses features of the COS waveform to provide information about hemodynamics.

This study is designed as an observational study to collect paired readings of the Cardiospire cardiogenic oscillation signal (COS) and the ground truth CO output parameters, including Pulmonary Artery Pressure diastolic (PAPd), systolic (PAPs), Stroke Volume (SV), and Cardiac Output (CO) from the Pulmonary Artery Catheter in intubated patients.

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
        • Contact:
          • Kamal Gupta, MD
          • Phone Number: 913-588-1227

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intubated patients in the ICU

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • Intubated
  • Pulmonary artery catheter
  • Patient or patient's legally authorized representative is able to provide informed consent

Exclusion Criteria:

  • Subjects who, at the principal investigator's determination, would not be appropriate for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeatable Data Verification
Time Frame: 3 months
First 10 patient Cardiospire data will be processed and analyzed to determine if deemed repeatable for cardiogenic oscillations (COS).
3 months
Correlation and Validation of data
Time Frame: 1.5 years
Collected Cardiospire data from next 150 patients will be analyzed in comparison to PAC data for correlation and validation purposes.
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Respirix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2021

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

September 15, 2023

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 6, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 12, 2021

Last Update Submitted That Met QC Criteria

August 6, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • CRD-02-1511

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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