Cardiac Output Assessment by Using Saline Contrast Injection

Recruiting

• Conditions: Echocardiography
• Interventions: Other: contrast assessment of cardiac output (CO); Other: cardiac Doppler technique

• Registration Number: NCT04310904
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Study Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2020-03-13
• Study First Submitted QC: 2020-03-13
• Study First Posted: 2020-03-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU cardiac output (CO) assessment patients	contrast assessment of cardiac output (CO)	all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.
ICU cardiac output (CO) assessment patients	cardiac Doppler technique	all ICU patients intubated/ventilated with a central line and an arterial catheter who need trans esophageal echocardiography examination with a saline contrast test.

Primary Outcome Measures

Name	Time	Method
variation of cardiac output assessment (CO)	day 0	correlation will be done between contrast and the reference method cardiac Doppler method.

Secondary Outcome Measures

Name	Time	Method
variation of cardiac output assessment (CO) in patients with a swan gaz catheter	day 0	comparison will be performed between the contrast CO and the thermodilution CO in the group of patients with a swan ganz catheter

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France