NCT05035719

Brief Summary

Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 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

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

August 31, 2021

Last Update Submit

September 1, 2021

Conditions

Cardiac Output, Low

Outcome Measures

Primary Outcomes (1)

  • Cardiac output performance comparison

    Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.

    Change between several paired readings over the course of cardiac surgery (typically 2-4 hours)

Study Arms (1)

Group 1

Cardiac patients

Device: non-invasive cardiac output monitor

Interventions

non-invasive cardiac output monitorDEVICE

Equivalence of Caretaker cardiac output reading to reference standard

Also known as: Equivalence of Caretaker cardiac output reading to reference standard
Group 1

Eligibility Criteria

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

Cardiac patients

You may qualify if:

  • years of age
  • able and willing to participate
  • provide written consent

You may not qualify if:

  • Unable to give written consent
  • \<18 years of age
  • No or poor finger pulse, as determined through visual inspection for ischemic hands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

RECRUITING

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Martin C Baruch, PhD

CONTACT

434 978-7000martin@caretakermedical.net

Study Design

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

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 5, 2021

Study Start

March 1, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

US(1)