Correlation of Hemodynamics Via Pulmonary Artery Catherization and the Cardiospire

NCT ID: NCT05003011

Last Updated: 2021-08-12

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

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hemodynamic Instability

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiospire

Non-invasive hemodynamic monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Respirix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Central Contacts

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Carin Lindquist

Role: CONTACT

4159268616

Facility Contacts

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Kamal Gupta, MD

Role: primary

913-588-1227

Other Identifiers

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CRD-02-1511

Identifier Type: -

Identifier Source: org_study_id

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