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Clinical Trials/NCT04310904
NCT04310904
Recruiting
Not Applicable

Cardiac Output Assessment by Using Saline Contrast Injection

Centre Hospitalier Universitaire, Amiens1 site in 1 country65 target enrollmentMarch 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Echocardiography
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
65
Locations
1
Primary Endpoint
variation of cardiac output assessment (CO)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Cardiac output (CO) assessment is one of the cornerstone of hemodynamic evaluation in ICU patients. CO is usually measured using invasive methods or non-invasive methods. Thermodilution is considered as the gold standard for CO assessment. Cardiac Doppler as well demonstrated to be accurate but needs manipulations and good knowledge and skills. The investigators developed a new technique using injection of agitated saline solution to evaluate CO without any manual measurement and then observer independent.

Detailed Description

The investigators decided to conduct a prospective observational study to compare contrast assessment of CO and cardiac Doppler technique. Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.

Registry
clinicaltrials.gov
Start Date
March 10, 2020
End Date
March 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.

Exclusion Criteria

  • patients under 18 years old
  • pregnant patients
  • moribund patients

Outcomes

Primary Outcomes

variation of cardiac output assessment (CO)

Time Frame: day 0

correlation will be done between contrast and the reference method cardiac Doppler method.

Secondary Outcomes

  • variation of cardiac output assessment (CO) in patients with a swan gaz catheter(day 0)

Study Sites (1)

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