Impact of Positive End-expiratory Pressure on Hepatic Venous Flow
Primary Purpose
Valvular Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low PEEP conventional ventilation
moderate PEEP conventional ventilation
low PEEP protective ventilation
moderate PEEP protective ventilation
Sponsored by
About this trial
This is an interventional supportive care trial for Valvular Heart Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
low PEEP conventional ventilation
moderate PEEP conventional ventilation
low PEEP protective ventilation
moderate PEEP protective ventilation
Arm Description
PEEP 2 mmHg tidal volume 10ml/kg
PEEP 7 mmHg tidal volume 10ml/kg
PEEP 2 mmHg with tidal volume 6 ml/kg
PEEP 7 mmHg tidal volume 6ml/kg
Outcomes
Primary Outcome Measures
forward hepatic venous flow
Hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
Secondary Outcome Measures
reversed hepatic venous flow
Reversed hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
Full Information
NCT ID
NCT02700581
First Posted
February 23, 2016
Last Updated
March 1, 2016
Sponsor
Konkuk University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02700581
Brief Title
Impact of Positive End-expiratory Pressure on Hepatic Venous Flow
Official Title
Impact of Moderate Positive End-expiratory Pressure on Hepatic Venous Flow in Patients Undergoing Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
May 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
sum of forward hepatic venous flow
sum of backward hepatic venous flow
peak velocity of diastolic hepatic venous flow
lung compliance
peak airway pressure
mean airway pressure
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low PEEP conventional ventilation
Arm Type
Active Comparator
Arm Description
PEEP 2 mmHg tidal volume 10ml/kg
Arm Title
moderate PEEP conventional ventilation
Arm Type
Experimental
Arm Description
PEEP 7 mmHg tidal volume 10ml/kg
Arm Title
low PEEP protective ventilation
Arm Type
Experimental
Arm Description
PEEP 2 mmHg with tidal volume 6 ml/kg
Arm Title
moderate PEEP protective ventilation
Arm Type
Experimental
Arm Description
PEEP 7 mmHg tidal volume 6ml/kg
Intervention Type
Procedure
Intervention Name(s)
low PEEP conventional ventilation
Intervention Type
Procedure
Intervention Name(s)
moderate PEEP conventional ventilation
Intervention Type
Procedure
Intervention Name(s)
low PEEP protective ventilation
Intervention Type
Procedure
Intervention Name(s)
moderate PEEP protective ventilation
Primary Outcome Measure Information:
Title
forward hepatic venous flow
Description
Hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
Time Frame
3 min after intervention
Secondary Outcome Measure Information:
Title
reversed hepatic venous flow
Description
Reversed hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
Time Frame
3 min after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Yop Kim, MD, PhD
Phone
+82222926942
Email
taeyop@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Positive End-expiratory Pressure on Hepatic Venous Flow
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