NCT05003011

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

1.5 years

First QC Date

August 6, 2021

Last Update Submit

August 6, 2021

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (2)

  • Repeatable Data Verification

    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

    Collected Cardiospire data from next 150 patients will be analyzed in comparison to PAC data for correlation and validation purposes.

    1.5 years

Interventions

CardiospireDEVICE

Non-invasive hemodynamic monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intubated patients in the ICU

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Central Study Contacts

Carin Lindquist

CONTACT

4159268616clindquist@theranova.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 12, 2021

Study Start

September 15, 2021

Primary Completion

March 15, 2023

Study Completion

September 15, 2023

Last Updated

August 12, 2021

Record last verified: 2021-08

Locations

US(1)