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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04774978
Other study ID # RijnstateH
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date July 1, 2022

Study information

Verified date February 2021
Source Rijnstate Hospital
Contact B Baten
Phone 088 - 0057870
Email BBaten@rijnstate.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Rationale: Study to assess the feasibility of real-time automatic cardiac output measurements using transthoracic echocardiography (TTE) Objective: To assess the correlation and feasibility of real-time automatic continuous cardiac output measurements using transthoracic ultrasound (TTE) in adult ICU-patients in comparison to Flotrac measurements Study design: prospective, feasibility study Study population: Adult Intensive Care patients ( > 18 years) Intervention (if applicable): Consecutive adult patients on the ICU in which the there is an indication for continuous cardiac output measurements. Main study parameters/endpoints: - Percentage of patients in which continuous cardiac output can be measured using TTE - Correlation between continuous TTE and Flotrac measurements


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date July 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult Intensive Care patients ( > 18 years) Exclusion Criteria: - Pregnancy - Atrial fibrillation or other irregular heart rhythm

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TTE
Transthoracic echocardiography

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rijnstate Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Patients in which the ProbeFix can be used continuously Percentages will be reported 2 months
Secondary Correlation between continuous TTE and Flotrac Bland-Altman plot will be reported 2 months
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