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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis; Lymphangioleiomyomatosis; Primary Pulmonary Hypertension; ARDS (Acute Respiratory Distress Syndrome); COPD (Chronic Obstructive Pulmonary Disease); Interstitial Pulmonary Fibrosis ARDS
• Intervention / Treatment: Procedure: Veno-veno-arterial ECMO

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. scheduled for double lung transplantation

Exclusion Criteria:

1. patients who have history of coronary artery occlusive disease
2. patients with arrhythmia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Veno-veno-arterial ECMO group	Procedure: Veno-veno-arterial ECMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
arterial blood oxygen partial pressure (PaO2)	5 min after jugular catheter flow 0ml/min
arterial blood oxygen partial pressure (PaO2)	5 min after jugular catheter flow 500 ml/min
arterial blood oxygen partial pressure (PaO2)	5 min after jugular catheter flow 1,000ml/min
arterial blood oxygen partial pressure (PaO2)	5 min after jugular catheter flow 1,500ml/min

Secondary Outcome Measures

Outcome Measure	Time Frame
venous blood oxygen partial pressure (PvO2)	5 min after jugular catheter flow 0ml/min
venous blood oxygen partial pressure (PvO2)	5 min after jugular catheter flow 500 ml/min
venous blood oxygen partial pressure (PvO2)	5 min after jugular catheter flow 1,000ml/min
venous blood oxygen partial pressure (PvO2)	5 min after jugular catheter flow 1,500ml/min

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2016
• Primary Completion (Actual): October 14, 2016
• Study Completion (Actual): October 14, 2016

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 18, 2018
• Last Update Submitted That Met QC Criteria: July 15, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Bronchial Diseases; Lung Injury; Lymphangiomyoma; Lymphatic Vessel Tumors; Perivascular Epithelioid Cell Neoplasms; Infant, Premature, Diseases; Hypertension; Bronchiectasis; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Lymphangioleiomyomatosis; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 4-2016-0124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO