Interstitial Pulmonary Fibrosis ARDSNCT02859194
The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients
A study testing Veno-veno-arterial ECMO in people with Interstitial Pulmonary Fibrosis ARDS and COPD (Chronic Obstructive Pulmonary Disease), run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Interstitial Pulmonary Fibrosis ARDS, COPD (Chronic Obstructive Pulmonary Disease), Bronchiectasis
- What is being tested?
- Veno-veno-arterial ECMO
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2016to 14 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. scheduled for double lung transplantation
Who cannot join
- patients who have history of coronary artery occlusive disease
- patients with arrhythmia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 120-752
About this study
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.
- Conditions
- Interstitial Pulmonary Fibrosis ARDS, COPD (Chronic Obstructive Pulmonary Disease), Bronchiectasis, Lymphangioleiomyomatosis, Primary Pulmonary Hypertension, ARDS (Acute Respiratory Distress Syndrome)
- Being tested
- Veno-veno-arterial ECMO
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiectasis, Lymphangioleiomyomatosis, Familial Primary Pulmonary Hypertension, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veno-veno-arterial ECMOProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Veno-veno-arterial ECMO group | Experimental | Not described Receives: Procedure: Veno-veno-arterial ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood oxygen partial pressure (PaO2)
Measured: 5 min after jugular catheter flow 0ml/min
arterial blood oxygen partial pressure (PaO2)
Measured: 5 min after jugular catheter flow 500 ml/min
arterial blood oxygen partial pressure (PaO2)
Measured: 5 min after jugular catheter flow 1,000ml/min
arterial blood oxygen partial pressure (PaO2)
Measured: 5 min after jugular catheter flow 1,500ml/min
Secondary outcomes (4)
venous blood oxygen partial pressure (PvO2)
Measured: 5 min after jugular catheter flow 0ml/min
venous blood oxygen partial pressure (PvO2)
Measured: 5 min after jugular catheter flow 500 ml/min
venous blood oxygen partial pressure (PvO2)
Measured: 5 min after jugular catheter flow 1,000ml/min
venous blood oxygen partial pressure (PvO2)
Measured: 5 min after jugular catheter flow 1,500ml/min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start31 May 2016
- Primary completion14 Oct 2016
- Study completion14 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Pulmonary Fibrosis ARDSStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859194
- Sponsor's protocol ID
- 4-2016-0124
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lt to Rt Shunt Using Veno-veno-arterial Extracorporeal Membrane Oxygenation (ECMO) on Coronary Oxygenation in Lung Transplantation Patients
- ClinicalTrials.gov ID
- NCT02859194
- Acronym / sponsor ID
- 4-2016-0124
- Conditions
- Interstitial Pulmonary Fibrosis ARDS, COPD (Chronic Obstructive Pulmonary Disease), Bronchiectasis, Lymphangioleiomyomatosis, Primary Pulmonary Hypertension, ARDS (Acute Respiratory Distress Syndrome)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 14 Oct 2016 (actual)
- Study completion
- 14 Oct 2016 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veno-veno-arterial ECMO group | Experimental | Procedure: Veno-veno-arterial ECMO |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. scheduled for double lung transplantation
Key exclusion criteria (2 listed)
- patients who have history of coronary artery occlusive disease
- patients with arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veno-veno-arterial ECMO | Procedure or surgery | Veno-veno-arterial ECMO group |
Primary outcome
arterial blood oxygen partial pressure (PaO2)
Time frame: 5 min after jugular catheter flow 0ml/min
arterial blood oxygen partial pressure (PaO2)
Time frame: 5 min after jugular catheter flow 500 ml/min
arterial blood oxygen partial pressure (PaO2)
Time frame: 5 min after jugular catheter flow 1,000ml/min
arterial blood oxygen partial pressure (PaO2)
Time frame: 5 min after jugular catheter flow 1,500ml/min
4 secondary outcomes
venous blood oxygen partial pressure (PvO2)
Time frame: 5 min after jugular catheter flow 0ml/min
venous blood oxygen partial pressure (PvO2)
Time frame: 5 min after jugular catheter flow 500 ml/min
venous blood oxygen partial pressure (PvO2)
Time frame: 5 min after jugular catheter flow 1,000ml/min
venous blood oxygen partial pressure (PvO2)
Time frame: 5 min after jugular catheter flow 1,500ml/min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veno-veno-arterial ECMO in people with Interstitial Pulmonary Fibrosis ARDS and COPD (Chronic Obstructive Pulmonary Disease), run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
arterial blood oxygen partial pressure (PaO2) (time frame: 5 min after jugular catheter flow 0ml/min). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.