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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
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Valvular Heart Disease

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 23, 2016
    Last Updated
    March 1, 2016
    Sponsor
    Konkuk University Medical Center
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    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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