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

NCT ID: NCT03485833

Last Updated: 2018-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EEO and EIO test

Intervention Type DIAGNOSTIC_TEST

velocity time integral of the aorta measured by transesophageal echocardiography after end-expiratory and end-inspiratory occlusion test

Interventions

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EEO and EIO test

velocity time integral of the aorta measured by transesophageal echocardiography after end-expiratory and end-inspiratory occlusion test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guo-wei Tu, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Zhongshan hospital, Fudan university

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhe Luo, PhD

Role: CONTACT

021-64041990 ext. 3659

Facility Contacts

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Guo-wei Tu, PhD

Role: primary

Other Identifiers

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EEOFR

Identifier Type: -

Identifier Source: org_study_id

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