NCT04774978

Brief Summary

Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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

February 25, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

February 25, 2021

Last Update Submit

February 25, 2021

Conditions

Cardiac Output, Low

Keywords

Cardiac outputTTE

Outcome Measures

Primary Outcomes (1)

  • Patients in which the ProbeFix can be used continuously

    Percentages will be reported

    2 months

Secondary Outcomes (1)

  • Correlation between continuous TTE and Flotrac

    2 months

Study Arms (1)

Cardiac output measurements

EXPERIMENTAL

Cardiac output will be measured using TTE continuously with ProbeFix

Device: TTE

Interventions

TTEDEVICE

Transthoracic echocardiography

Cardiac output measurements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Intensive Care patients ( \> 18 years)

You may not qualify if:

  • Pregnancy
  • Atrial fibrillation or other irregular heart rhythm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

B Baten

CONTACT

088 - 0057870BBaten@rijnstate.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 1, 2021

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

July 1, 2022

Last Updated

March 1, 2021

Record last verified: 2021-02