Critical IllnessNCT05778292
Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT
An observational study of Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to investigate the feasibility of using electric impedance tomography (EIT) to monitor lung perfusion during veno-venous (VV) extracopreal membrane oxygenation (ECMO) support, as well as the effect of different ECMO flows on lung perfusion monitored by EIT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Critical Illness
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with respiratory failure supported on VV ECMO
Who may be able to join
- Patients aged ≥ 18 and ≤ 70 years；
- Patients supported with VV ECMO for respiratory failure；
- Patients are intubated and mechanically ventilated.
Who cannot join
- EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;
- Patients who did not sign the informed consent form;
- Pulmonary embolism;
- Pneumothorax;
- Medium to plenty of chest water;
- Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;
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- Refractory shock;
- Severe chronic heart and lung disease has existed in the past;
- BMI>35 kg/m2;
- Intra-abdominal pressure >20mmHg.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiaobo Yang
Wuhan, Hubei, 430022
Xiaobo Yang, Prof., +862785351606, want.tofly@aliyun.com
About this study
Official title: Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT: an Observational Study
The purpose of this study is to investigate the feasibility of using electric impedance tomography (EIT) to monitor lung perfusion during veno-venous (VV) extracopreal membrane oxygenation (ECMO) support, as well as the effect of different ECMO flows on lung perfusion monitored by EIT.
Read the detailed description
This is a monocentric obsevensional study that uses EIT to monitor lung perfusion during VV ECMO support and the effect of different ECMO flows on lung perfusion as measured by EIT. Patients on VV ECMO who meet the withdrawal criteria as determined by clinical experts will have their ECMO flow gradually reduced. EIT lung ventilation and perfusion monitoring were performed at various ECMO flows.
- Conditions
- Critical Illness
- Keywords
- VV ECMO, EIT, Lung perfusion
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung perfusion at different VV ECMO flows
Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung perfusion distribution Monitored by EIT
Measured: up to 24hour
Secondary outcomes (5)
Lung ventilation at different VV ECMO flows
Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung ventilation distribution monitored by EIT
Measured: up to 24hour
Lung deadspace region at different VV ECMO flows
Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung deadspace region monitored by EIT
Measured: up to 24hour
Lung shunt region at different VV ECMO flows
Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung shunt region monitored by EIT
Measured: up to 24hour
Lung ventilation/perfusion matching at different VV ECMO flows
Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung ventilation/perfusion matching monitored by EIT
Measured: up to 24hour
Recirculation at different VV ECMO flows
Recirculation at different VV ECMO flows (ECMO flow at 4.5L,3.5L,2.5L,and1.5L)
Measured: up to 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Yang, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778292
- Sponsor's protocol ID
- ECMO20221119
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different VV ECMO Flows on Lung Perfusion Monitored by EIT: an Observational Study
- ClinicalTrials.gov ID
- NCT05778292
- Acronym / sponsor ID
- ECMO20221119
- Conditions
- Critical Illness
- Keywords
- VV ECMO, EIT, Lung perfusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Mar 2023 (actual)
- 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.
The purpose of this study is to investigate the feasibility of using electric impedance tomography (EIT) to monitor lung perfusion during veno-venous (VV) extracopreal membrane oxygenation (ECMO) support, as well as the effect of different ECMO flows on lung perfusion monitored by EIT.
Detailed description
This is a monocentric obsevensional study that uses EIT to monitor lung perfusion during VV ECMO support and the effect of different ECMO flows on lung perfusion as measured by EIT. Patients on VV ECMO who meet the withdrawal criteria as determined by clinical experts will have their ECMO flow gradually reduced. EIT lung ventilation and perfusion monitoring were performed at various ECMO flows.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with respiratory failure supported on VV ECMO
Key inclusion criteria (3 listed)
- Patients aged ≥ 18 and ≤ 70 years；
- Patients supported with VV ECMO for respiratory failure；
- Patients are intubated and mechanically ventilated.
Key exclusion criteria (10 listed)
- EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;
- Patients who did not sign the informed consent form;
- Pulmonary embolism;
- Pneumothorax;
- Medium to plenty of chest water;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung perfusion at different VV ECMO flows
Time frame: up to 24hour
Effect of Different VV ECMO Flows (ECMO flow at 4.5L,3.5L,2.5L,1.5L, and after ECMO withdrawal) on lung perfusion distribution Monitored by EIT
5 secondary outcomes
Lung ventilation at different VV ECMO flows
Time frame: up to 24hour
Lung deadspace region at different VV ECMO flows
Time frame: up to 24hour
Lung shunt region at different VV ECMO flows
Time frame: up to 24hour
Lung ventilation/perfusion matching at different VV ECMO flows
Time frame: up to 24hour
Recirculation at different VV ECMO flows
Time frame: up to 24hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Mar 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaobo Yang, prof. (008602785351606, want.tofly@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung perfusion at different VV ECMO flows (time frame: up to 24hour). 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 21 Mar 2023.