Impact of Positive End-expiratory Pressure on Hepatic Venous Flow

March 1, 2016 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Impact of Moderate Positive End-expiratory Pressure on Hepatic Venous Flow in Patients Undergoing Cardiac Surgery

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: low PEEP conventional ventilation
PEEP 2 mmHg tidal volume 10ml/kg
Procedure: low PEEP conventional ventilation
Experimental: moderate PEEP conventional ventilation
PEEP 7 mmHg tidal volume 10ml/kg
Procedure: moderate PEEP conventional ventilation
Experimental: low PEEP protective ventilation
PEEP 2 mmHg with tidal volume 6 ml/kg
Procedure: low PEEP protective ventilation
Experimental: moderate PEEP protective ventilation
PEEP 7 mmHg tidal volume 6ml/kg
Procedure: moderate PEEP protective ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
forward hepatic venous flow
Time Frame: 3 min after intervention
Hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
3 min after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reversed hepatic venous flow
Time Frame: 3 min after intervention
Reversed hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography
3 min after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 7, 2016

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH000000 TBD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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