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The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients

The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04102072
Enrollment
20
Registered
2019-09-25
Start date
2019-08-23
Completion date
2024-08-31
Last updated
2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extracorporeal Membrane Oxygenation

Keywords

pulmonary artery catheter, echocardiography, fluid responsiveness, extracorporeal membrane oxygenation

Brief summary

Objective: 1. To evaluate the consistency of cardiac output measured by different hemodynamic monitoring methods in patients with VA-ECMO 2. To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes

Detailed description

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been used for profound cardiogenic shock to bridge to decision,ventricular assist devices,or transplant.Close monitoring of cardiac output, especially in patients before and after intervention (such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), can help to adjust the treatment strategy. Hemodynamic monitoring in ECMO patients requires familiarity with the underlying pathophysiology and circulatory mechanics of extracorporeal flow.Limited to the actual clinical situation of patients, one or two hemodynamic monitoring methods may be accepted. Is there consistency between different hemodynamic monitoring results? And whether hemodynamic monitoring can accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. This study will provide important reference for VA-ECMO patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.

Interventions

DIAGNOSTIC_TESTTrendelenburg Maneuver

In the Trendelenburg position, the body is laid supine with the feet higher than the head by 15-30 degrees. The venous return increases in the trendelenburg position which in turn increases the stroke volume.

DIAGNOSTIC_TESTdobutamine stress test

Dobutamine was infused intravenously at the initial dose of 2.5 ug/kg/min. Echocardiography was performed after 5-10 minutes of continuous infusion, and hemodynamic data were recorded.

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. cardiac surgery 2. treatment with VA-ECMO 3. mechanical ventilation 4. hemodynamic monitoring according to patient's condition (PAC, Flotrac, echocardiography)

Exclusion criteria

1. age \< 18 2. cardiac arrhythmia 3. moderate to severe aortic, mitral and tricuspid regurgitation 4. active hemorrhage 5. IABP 6. spontaneous triggering of the ventilator

Design outcomes

Primary

MeasureTime frameDescription
Baseline Cardiac Output measurementwithin1 minute at baseline positionCardiac Output measured at baseline position( in a supine position with the head elevated to 15° for baseline measurements )
Cardiac Output measurement afterTrendelenburg Maneuver1 minute after starting Trendelenburg ManeuverCardiac Output measured after Trendelenburg Maneuver
Cardiac Output measurement after Dobutamine stress test5 minutes after dobutamine stress testCardiac Output measured after dobutamine stress test

Countries

China

Contacts

Primary ContactGuo-wei Tu, Doctor
tu.guowei@zs-hospital.sh.cn86-021-64041990
Backup ContactJun-yi Hou, Doctor
hou.junyi@zs-hospital.sh.cn86-021-64041990

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026