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

Not Applicable

• Conditions: Cardiac Surgery
• Interventions: Diagnostic Test: EEO and EIO test

• Registration Number: NCT03485833
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-03
• Study First Submitted: 2018-03-24
• Study First Submitted QC: 2018-03-30
• Last Update Submitted: 2018-03-30
• Study First Posted: 2018-04-02
• Last Update Posted: 2018-04-02
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EEO and EIO test	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.

Primary Outcome Measures

Name	Time	Method
responders	within 1 minute after volume expansion	responders are defined by volume time integral increases over 15% after volume expansion of 5ml/kg crystalloid

Secondary Outcome Measures

Name	Time	Method
nonresponders	within 1 minute after volume expansion	nonresponders are defined by volume time integral increases less than 15% after volume expansion of 5ml/kg crystalloid

Trial Locations

Locations (1)

Zhongshan hospital, Fudan university; 🇨🇳 Shanghai, Shanghai, China