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

NCT04102072 | Unknown DMC

• 1 other identifier: COMMENT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Objective：

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

Conditions

Extracorporeal Membrane Oxygenation

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Baseline Cardiac Output measurement

  Cardiac Output measured at baseline position（ in a supine position with the head elevated to 15° for baseline measurements ）

  within1 minute at baseline position

• Cardiac Output measurement afterTrendelenburg Maneuver

  Cardiac Output measured after Trendelenburg Maneuver

  1 minute after starting Trendelenburg Maneuver

• Cardiac Output measurement after Dobutamine stress test

  Cardiac Output measured after dobutamine stress test

  5 minutes after dobutamine stress test

Study Arms (2)

Trendelenburg Maneuver

EXPERIMENTAL

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.

Diagnostic Test: Trendelenburg Maneuver

dobutamine stress test

EXPERIMENTAL

Dobutamine is a selective beta 1 receptor agonist. It \[\<10 ug/(kg.min)\] can effectively increase myocardial contractility.

Diagnostic Test: dobutamine stress test

Interventions

Trendelenburg Maneuver DIAGNOSTIC_TEST

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.

Trendelenburg Maneuver

dobutamine stress test DIAGNOSTIC_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.

dobutamine stress test

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cardiac surgery
• treatment with VA-ECMO
• mechanical ventilation
• hemodynamic monitoring according to patient's condition (PAC, Flotrac, echocardiography)

You may not qualify if:

• age \< 18
• cardiac arrhythmia
• moderate to severe aortic, mitral and tricuspid regurgitation
• active hemorrhage
• IABP
• spontaneous triggering of the ventilator

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, 200032, China

RECRUITING

Study Officials

• Zhe Luo, Doctor

  Fudan University

  STUDY CHAIR

Central Study Contacts

Guo-wei Tu, Doctor

CONTACT

86-021-64041990; tu.guowei@zs-hospital.sh.cn

Jun-yi Hou, Doctor

CONTACT

86-021-64041990; hou.junyi@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 25, 2019
• Study Start: August 23, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

CN (1)