Impact of Positive End-expiratory Pressure on Hepatic Venous Flow

Not Applicable

• Conditions: Valvular Heart Disease
• Interventions: Procedure: low PEEP conventional ventilation; Procedure: moderate PEEP conventional ventilation; Procedure: low PEEP protective ventilation; Procedure: moderate PEEP protective ventilation

• Registration Number: NCT02700581
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

The purpose of this study is to determine the difference in the impact of moderate positive end-expiratory pressure (PEEP) on hepatic venous flow Doppler in patients undergoing cardiac surgery: conventional versus protective ventilation strategy The possible changes in forward and backward flows (Doppler profiles) of hepatic venous flow at different degrees of PEEP in conventional and protective ventilation strategies are analyzed by using intraoperative transesophageal echocardiography (TEE) in patients undergoing cardiac surgery .

Detailed Description

Following data would be determined after 5 min-exposure volume controlled ventilation employing tidal volume of 10 ml/kg and 6 ml/kg with low PEEP (with 2 mmHg) and moderate PEEP (7 mmHg) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=12)

1. sum of forward hepatic venous flow

2. sum of backward hepatic venous flow

3. peak velocity of diastolic hepatic venous flow

4. lung compliance

5. peak airway pressure

6. mean airway pressure

7. other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (CVP), pulmonary capillary

Study Timeline

• Study First Submitted: 2016-02-23
• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-01
• Last Update Submitted: 2016-03-01
• Study First Posted: 2016-03-07
• Last Update Posted: 2016-03-07
• Primary Completion: 2016-04
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients undergoing cardiac surgery
• Patients provide written informed consents

Exclusion Criteria

• Re-do or tri-do surgery
• Patients with active infection
• Patients with endocrine disease
• Patients ischemic heart disease
• patients with tricuspid valve regurgitation greater than mild degree

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low PEEP conventional ventilation	low PEEP conventional ventilation	PEEP 2 mmHg tidal volume 10ml/kg
moderate PEEP conventional ventilation	moderate PEEP conventional ventilation	PEEP 7 mmHg tidal volume 10ml/kg
low PEEP protective ventilation	low PEEP protective ventilation	PEEP 2 mmHg with tidal volume 6 ml/kg
moderate PEEP protective ventilation	moderate PEEP protective ventilation	PEEP 7 mmHg tidal volume 6ml/kg

Primary Outcome Measures

Name	Time	Method
forward hepatic venous flow	3 min after intervention	Hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography

Secondary Outcome Measures

Name	Time	Method
reversed hepatic venous flow	3 min after intervention	Reversed hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography