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

Cardiac Surgery Clinical Trial

— EEOFR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03485833
• Other study ID #: EEOFR
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2018
• Last updated: March 30, 2018
• Start date: January 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Zhe Luo, PhD
• Phone: 021-64041990
• Email: luo.zhe[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Respiratory Aspiration

Intervention

Diagnostic Test:
• EEO and EIO test
velocity time integral of the aorta measured by transesophageal echocardiography after end-expiratory and end-inspiratory occlusion test

Locations

Country	Name	City	State
China	Zhongshan hospital, Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	responders	responders are defined by volume time integral increases over 15% after volume expansion of 5ml/kg crystalloid	within 1 minute after volume expansion
Secondary	nonresponders	nonresponders are defined by volume time integral increases less than 15% after volume expansion of 5ml/kg crystalloid	within 1 minute after volume expansion