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The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients

Primary Purpose

Interstitial Pulmonary Fibrosis ARDS, COPD (Chronic Obstructive Pulmonary Disease), Bronchiectasis

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Veno-veno-arterial ECMO

About this trial

This is an interventional treatment trial for Interstitial Pulmonary Fibrosis ARDS

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. scheduled for double lung transplantation

Exclusion Criteria:

patients who have history of coronary artery occlusive disease
patients with arrhythmia

Sites / Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Veno-veno-arterial ECMO group

Arm Description

Outcomes

Primary Outcome Measures

arterial blood oxygen partial pressure (PaO2)

Secondary Outcome Measures

venous blood oxygen partial pressure (PvO2)

Full Information

NCT ID

NCT02859194

First Posted

July 21, 2016

Last Updated

July 15, 2018

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02859194

Brief Title

The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

May 31, 2016 (Actual)

Primary Completion Date

October 14, 2016 (Actual)

Study Completion Date

October 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

ECMO(Extracorporeal membrane oxygenation) is being essential for cardiopulmonary failure patients. There are two types of ECMO, which is veno-veno (V-V) that can be used in respiratory failure patients and veno-arterial (V-A) that can be used in cardiac failure patients. V-A ECMO can also be used during lung transplantation, substitution of cardiopulmonary bypass, which can show sufficient performance during operation and better postoperative outcome. However, regarding V-A ECMO circulating from femoral vein to femoral artery, there is a pro blem of differential hypoxia which might influence coronary artery and head vessels. In this prospective study, the investigators are planning to put another ECMO catheter into internal jugular vein which takes a role of left to right shunt, to mitigate the hypoxia of coronary artery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Interstitial Pulmonary Fibrosis ARDS, COPD (Chronic Obstructive Pulmonary Disease), Bronchiectasis, Lymphangioleiomyomatosis, Primary Pulmonary Hypertension, ARDS (Acute Respiratory Distress Syndrome)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Veno-veno-arterial ECMO group

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Veno-veno-arterial ECMO

Primary Outcome Measure Information:

Title

arterial blood oxygen partial pressure (PaO2)

Time Frame

5 min after jugular catheter flow 0ml/min

Title

arterial blood oxygen partial pressure (PaO2)

Time Frame

5 min after jugular catheter flow 500 ml/min

Title

arterial blood oxygen partial pressure (PaO2)

Time Frame

5 min after jugular catheter flow 1,000ml/min

Title

arterial blood oxygen partial pressure (PaO2)

Time Frame

5 min after jugular catheter flow 1,500ml/min

Secondary Outcome Measure Information:

Title

venous blood oxygen partial pressure (PvO2)

Time Frame

5 min after jugular catheter flow 0ml/min

Title

venous blood oxygen partial pressure (PvO2)

Time Frame

5 min after jugular catheter flow 500 ml/min

Title

venous blood oxygen partial pressure (PvO2)

Time Frame

5 min after jugular catheter flow 1,000ml/min

Title

venous blood oxygen partial pressure (PvO2)

Time Frame

5 min after jugular catheter flow 1,500ml/min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. scheduled for double lung transplantation Exclusion Criteria: patients who have history of coronary artery occlusive disease patients with arrhythmia

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients

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