NCT02859194

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2016

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

5 months

First QC Date

July 21, 2016

Last Update Submit

July 15, 2018

Conditions

Interstitial Pulmonary Fibrosis ARDSCOPD (Chronic Obstructive Pulmonary Disease)BronchiectasisLymphangioleiomyomatosisPrimary Pulmonary HypertensionARDS (Acute Respiratory Distress Syndrome)

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • 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

Study Arms (1)

Veno-veno-arterial ECMO group

EXPERIMENTAL
Procedure: Veno-veno-arterial ECMO

Interventions

Veno-veno-arterial ECMOPROCEDURE
Veno-veno-arterial ECMO group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. scheduled for double lung transplantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchiectasisLymphangioleiomyomatosisFamilial Primary Pulmonary HypertensionAcute Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesLymphangiomyomaNeoplasm, Lymphatic TissueNeoplasms by Histologic TypeNeoplasmsPerivascular Epithelioid Cell NeoplasmsNeoplasms, Connective and Soft TissueLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHypertension, PulmonaryLung Injury

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 8, 2016

Study Start

May 31, 2016

Primary Completion

October 14, 2016

Study Completion

October 14, 2016

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)