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Impact of Positive End-expiratory Pressure on Hepatic Venous Flow

NCT ID: NCT02700581

Last Updated: 2016-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-05-31

Brief Summary

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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 .

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Detailed Description

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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

Conditions

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Valvular Heart Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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low PEEP conventional ventilation

PEEP 2 mmHg tidal volume 10ml/kg

Group Type ACTIVE_COMPARATOR

low PEEP conventional ventilation

Intervention Type PROCEDURE

moderate PEEP conventional ventilation

PEEP 7 mmHg tidal volume 10ml/kg

Group Type EXPERIMENTAL

moderate PEEP conventional ventilation

Intervention Type PROCEDURE

low PEEP protective ventilation

PEEP 2 mmHg with tidal volume 6 ml/kg

Group Type EXPERIMENTAL

low PEEP protective ventilation

Intervention Type PROCEDURE

moderate PEEP protective ventilation

PEEP 7 mmHg tidal volume 6ml/kg

Group Type EXPERIMENTAL

moderate PEEP protective ventilation

Intervention Type PROCEDURE

Interventions

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low PEEP conventional ventilation

Intervention Type PROCEDURE

moderate PEEP conventional ventilation

Intervention Type PROCEDURE

low PEEP protective ventilation

Intervention Type PROCEDURE

moderate PEEP protective ventilation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Tae-Yop Kim, MD, PhD

Role: CONTACT

[email protected]
+82222926942

Other Identifiers

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KUH000000 TBD

Identifier Type: -

Identifier Source: org_study_id

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