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

March 30, 2018 updated by: Shanghai Zhongshan Hospital

End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness in Mechanically Ventilated Cardiac Surgical Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Contact:
          • Guo-wei Tu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EEO and EIO test
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.
Diagnostic test: EEO and EIO test
velocity time integral of the aorta measured by transesophageal echocardiography after end-expiratory and end-inspiratory occlusion test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
responders
Time Frame: within 1 minute after volume expansion
responders are defined by volume time integral increases over 15% after volume expansion of 5ml/kg crystalloid
within 1 minute after volume expansion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nonresponders
Time Frame: within 1 minute after volume expansion
nonresponders are defined by volume time integral increases less than 15% after volume expansion of 5ml/kg crystalloid
within 1 minute after volume expansion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

March 24, 2018

First Submitted That Met QC Criteria

March 30, 2018

First Posted (ACTUAL)

April 2, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EEOFR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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