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

Not Applicable

• Conditions: Extracorporeal Membrane Oxygenation
• Interventions: Diagnostic Test: Trendelenburg Maneuver; Diagnostic Test: dobutamine stress test

• Registration Number: NCT04102072
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2019-08-23
• Status Verified: 2019-09
• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-22
• Last Update Submitted: 2019-09-24
• Study First Posted: 2019-09-25
• Last Update Posted: 2019-09-26
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trendelenburg Maneuver	Trendelenburg Maneuver	The Trendelenburg position is a common treatment in medicine.It is used either as a diagnostic tool to assess fluid loading response or as a therapeutic maneuver pending fluid resuscitation.With the advantage of autotransfusion readily available,the Trendelenburg position is used for expected instantaneous effect on cardiovascular performance.
dobutamine stress test	dobutamine stress test	Dobutamine is a selective beta 1 receptor agonist. It \[\<10 ug/(kg.min)\] can effectively increase myocardial contractility.

Primary Outcome Measures

Name	Time	Method
Baseline Cardiac Output measurement	within1 minute at baseline position	Cardiac Output measured at baseline position（ in a supine position with the head elevated to 15° for baseline measurements ）
Cardiac Output measurement after Dobutamine stress test	5 minutes after dobutamine stress test	Cardiac Output measured after dobutamine stress test
Cardiac Output measurement afterTrendelenburg Maneuver	1 minute after starting Trendelenburg Maneuver	Cardiac Output measured after Trendelenburg Maneuver

Trial Locations

Locations (1)

Zhongshan hospital, Fudan university; 🇨🇳 Shanghai, China