Impact of Positive End-expiratory Pressure on Hepatic Venous Flow

Valvular Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02700581
• Other study ID #: KUH000000 TBD
• Status: Not yet recruiting
• Phase: N/A
• First received: February 23, 2016
• Last updated: March 1, 2016
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: March 2016
• Source: Konkuk University Medical Center
• Contact: Tae-Yop Kim, MD, PhD
• Phone: +82222926942
• Email: taeyop[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Procedure:
• low PEEP conventional ventilation

• moderate PEEP conventional ventilation

• low PEEP protective ventilation

• moderate PEEP protective ventilation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	forward hepatic venous flow	Hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography	3 min after intervention	No
Secondary	reversed hepatic venous flow	Reversed hepatic venous flow Doppler, cm/sec, by transesophageal echocardiography	3 min after intervention	No