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End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness (EEOFR)

Primary Purpose

Cardiac Surgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EEO and EIO test
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgery focused on measuring end-expiratory occlusion test, end-inspiratory occlusion test, transesophageal echocardiography, passive legs raising, fluid challenge

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cardiac surgical patients
  • hypotension after induction of anesthesia
  • required volume expansion by clinical judgement of the anesthesiologist

Exclusion Criteria:

  • younger than 18 years
  • severe valve regurgitation or systolic dysfunction of the right ventricle
  • contraindication of the transesophageal echocardiography examination
  • cardiac arrhythmia
  • left ventricular ejection fraction less than 30% before surgery

Sites / Locations

  • Zhongshan hospital, Fudan universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EEO and EIO test

Arm Description

velocity time integral of the aorta measured by transesophageal echocardiography during end expiratory and end inspiratory occlusion test to predict volume responsiveness.Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

Outcomes

Primary Outcome Measures

responders
responders are defined by volume time integral increases over 15% after volume expansion of 5ml/kg crystalloid

Secondary Outcome Measures

nonresponders
nonresponders are defined by volume time integral increases less than 15% after volume expansion of 5ml/kg crystalloid

Full Information

First Posted
March 24, 2018
Last Updated
March 30, 2018
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03485833
Brief Title
End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness
Acronym
EEOFR
Official Title
End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness in Mechanically Ventilated Cardiac Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.
Detailed Description
Patients with hypotension after anesthetic induction for cardiac surgery, who requires fluid resuscitation based on clinical judgement by the anesthesiologists are enrolled in this study. Patients are monitored by transesophageal echocardiography and FloTrac/Vigileo. Hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, central venous pressure, stroke volume variation, cardiac index, velocity time integral of the aorta etc) are measured at baseline, after end-expiratory occlusion (EEO) test, after end-inspiratory occlusion (EIO) test, after passive legs raising test, and after fluid challenge respectively. Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery
Keywords
end-expiratory occlusion test, end-inspiratory occlusion test, transesophageal echocardiography, passive legs raising, fluid challenge

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EEO and EIO test
Arm Type
Experimental
Arm Description
velocity time integral of the aorta measured by transesophageal echocardiography during end expiratory and end inspiratory occlusion test to predict volume responsiveness.Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.
Intervention Type
Diagnostic Test
Intervention Name(s)
EEO and EIO test
Intervention Description
velocity time integral of the aorta measured by transesophageal echocardiography after end-expiratory and end-inspiratory occlusion test
Primary Outcome Measure Information:
Title
responders
Description
responders are defined by volume time integral increases over 15% after volume expansion of 5ml/kg crystalloid
Time Frame
within 1 minute after volume expansion
Secondary Outcome Measure Information:
Title
nonresponders
Description
nonresponders are defined by volume time integral increases less than 15% after volume expansion of 5ml/kg crystalloid
Time Frame
within 1 minute after volume expansion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: cardiac surgical patients hypotension after induction of anesthesia required volume expansion by clinical judgement of the anesthesiologist Exclusion Criteria: younger than 18 years severe valve regurgitation or systolic dysfunction of the right ventricle contraindication of the transesophageal echocardiography examination cardiac arrhythmia left ventricular ejection fraction less than 30% before surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Luo, PhD
Phone
021-64041990
Ext
3659
Email
luo.zhe@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo-wei Tu, PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan hospital, Fudan university
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-wei Tu, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness

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