Perfusion; ComplicationsNCT04929873
Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology
A study testing Closed transdyser and Routine monitor in people with Perfusion; Complications, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Establish and verify the feasibility and effectiveness of VA-ECMO remote limb re-perfusion monitoring technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perfusion; Complications
- What is being tested?
- Closed transdyser and Routine monitor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: adult patients ≥ 18 years of age;
- signed ECMO informed consent;
- femur vein VA-ECMO treatment;
- agreed to establish VA-ECMO side branch cycle;
- informed consent to this study.
Who cannot join
- a completely closed double lower limb venously before surgery;
- amputee
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SAHZhejiangU
Hangzhou, Zhejiang, 310000
Fei Zeng, 13757119536, zengfei@zju.edu.cn
About this study
Establish and verify the feasibility and effectiveness of VA-ECMO remote limb re-perfusion monitoring technology.
Read the detailed description
It is proposed to monitor VA-ECMO arterial end side branch circulation in real time through a set of monitoring equipment, guide clinical adjustment, improve lower limb re-perfusion, reduce the occurrence of lower limb ischemia, in order to achieve the goal of early detection, early prevention and early treatment, and provide reference and theoretical basis for clinical practice.
Monitoring techniques are divided into two parts: A. monitoring equipment (connecting transdiotic monitoring pressure on va-ECMO side branches cycle); B.to guide clinical adjustment by monitoring pressure (average arterial pressure).
- Conditions
- Perfusion; Complications
- Being tested
- Closed transdyser, Routine monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed transdyserBehavioural
When the average arterial pressure ≥ 50mmHg, it is indicated that the basic blood supply of the lower extremities is satisfied without special treatment, and when the average arterial pressure < 50mmHg, it indicates insufficient perfusion, by adjusting the pipe position, changing the ECMO flow rate, and properly clamping the artery end to divert part of the blood flow to the side branch circulation, so that the average arterial pressure is maintained above 50mmHg.
Routine monitorBehavioural
Obtain oxygen saturation, skin color, temperature, etc
| Study group | Role | What they receive |
|---|---|---|
| routine treatment | Placebo comparator | routine nursing Receives: Behavioral: Routine monitor |
| Experimental group | Experimental | Immediately after the establishment of the side branch cycle, the closed transdone is connected for real-time monitoring of pressure, and clinical nursing practice is guided by transdictor pressure. Receives: Behavioral: Closed transdyser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ischemia Incidence of ischemia
of ischemia in the lower extremities on the side of the tube
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jan 2020
- Primary completion30 Oct 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perfusion; ComplicationsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- transdynation for real-time pressure monitoring
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fei Zeng, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929873
- Sponsor's protocol ID
- 2020-567
- Status last verified
- May 2021
- First submitted
- 1 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of VA-ECMO Remote Limb Re-perfusion Monitoring Technology
- ClinicalTrials.gov ID
- NCT04929873
- Acronym / sponsor ID
- 2020-567
- Conditions
- Perfusion; Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jun 2021 (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.
Establish and verify the feasibility and effectiveness of VA-ECMO remote limb re-perfusion monitoring technology.
Detailed description
It is proposed to monitor VA-ECMO arterial end side branch circulation in real time through a set of monitoring equipment, guide clinical adjustment, improve lower limb re-perfusion, reduce the occurrence of lower limb ischemia, in order to achieve the goal of early detection, early prevention and early treatment, and provide reference and theoretical basis for clinical practice.
Monitoring techniques are divided into two parts: A. monitoring equipment (connecting transdiotic monitoring pressure on va-ECMO side branches cycle); B.to guide clinical adjustment by monitoring pressure (average arterial pressure).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- transdynation for real-time pressure monitoring
| Arm | Type | Receives |
|---|---|---|
| routine treatment | Placebo comparator | Behavioral: Routine monitorroutine nursing |
| Experimental group | Experimental | Behavioral: Closed transdyserImmediately after the establishment of the side branch cycle, the closed transdone is connected for real-time monitoring of pressure, and clinical nursing practice is guided by transdictor pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: adult patients ≥ 18 years of age;
- signed ECMO informed consent;
- femur vein VA-ECMO treatment;
- agreed to establish VA-ECMO side branch cycle;
- informed consent to this study.
Key exclusion criteria (2 listed)
- a completely closed double lower limb venously before surgery;
- amputee
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 |
|---|---|---|
| Closed transdyserWhen the average arterial pressure ≥ 50mmHg, it is indicated that the basic blood supply of the lower extremities is satisfied without special treatment, and when the average arterial pressure < 50mmHg, it indicates insufficient perfusion, by adjusting the pipe position, changing the ECMO flow rate, and properly clamping the artery end to divert part of the blood flow to the side branch circulation, so that the average arterial pressure is maintained above 50mmHg. | Behavioural | Experimental group |
| Routine monitorObtain oxygen saturation, skin color, temperature, etc | Behavioural | routine treatment |
Primary outcome
Incidence of ischemia Incidence of ischemia
Time frame: 1 year
of ischemia in the lower extremities on the side of the tube
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Perfusion; Complications
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Recruiting
Perfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy
Postoperative Pain, Adenotonsillectomy
Recruiting
Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure
Acute Kidney Injury, Fluid Overload
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.
Fei Zeng study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed transdyser and Routine monitor in people with Perfusion; Complications, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 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: status not confirmed, as of the sponsor's last update on 18 Jun 2021. 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. Some participants in this study may receive a placebo. 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 Fei Zeng (13757119536, zengfei@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ischemia Incidence of ischemia (time frame: 1 year). 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 Jun 2021.