Extracorporeal Membrane Oxygenation ComplicationVV-ECMONCT04918498
Application of Early Physical Therapy Regimens in Patients With Veno-venos Extracorporeal Membrane Oxygenation
A study testing early physiotherapy programs and routine treatment in people with Extracorporeal Membrane Oxygenation Complication, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Promote early recovery through the application of early physiotherapy programs for VV-ECMO patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- early physiotherapy programs and routine treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 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
- VV-ECMO assisted support
- lung failure (e.g. ARDS)
- age ≥18 years
- sober
- informed consent to this study
Who cannot join
- unstable blood flow mechanics
- active bleeding
- mental disorders that do not work together
- people waiting for lung transplants
- people at the end of life (e.g. advanced lung cancer)
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
Promote early recovery through the application of early physiotherapy programs for VV-ECMO patients
Read the detailed description
This study is intended to construct early physiotherapy programs for VV-ECMO patients, including multidisciplinary team building, safety assessment, early active physiotherapy, respiratory physiotherapy, with a view to promoting early recovery of patients, early withdrawal of ventilator-assisted ventilation, shortening ECMO auxiliary time, improving patients' exercise level and respiratory function, reducing complications, and improving the quality of near-term and long-term survival.
- Being tested
- early physiotherapy programs, routine treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early physiotherapy programsBehavioural
establishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy
routine treatmentBehavioural
provide routine nursing and rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| routine treatment | Placebo comparator | Review the collection of patient-related clinical data, collation of clinical data and outcome indicators Receives: Behavioral: routine treatment |
| Experimental group | Experimental | Implement early physiotherapy programs. The early physiotherapy program for VV-ECMO patients mainly includes the establishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy. Receives: Behavioral: early physiotherapy programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
VV-ECMO auxiliary time
the time for VV-ECMO auxiliary
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 posted8 Jun 2021
- Study start1 Jan 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies 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
- Non-randomised
- Intervention model
- Factorial
- Model description
- Non-contemporaneous control
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Jiaxing University, Yuhang Hospital, Changxing People's Hospital
- Responsible party
- Sponsor
- Investigators
- Fei Zeng, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918498
- Sponsor's protocol ID
- 2021-0205
- Acronym
- VV-ECMO
- Status last verified
- May 2021
- First submitted
- 31 May 2021
- Last updated
- 15 Jul 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 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Early Physical Therapy Regimens in Patients With Veno-venos Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT04918498
- Acronym / sponsor ID
- VV-ECMO / 2021-0205
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Jiaxing University, Yuhang Hospital, Changxing People's Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 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.
Promote early recovery through the application of early physiotherapy programs for VV-ECMO patients
Detailed description
This study is intended to construct early physiotherapy programs for VV-ECMO patients, including multidisciplinary team building, safety assessment, early active physiotherapy, respiratory physiotherapy, with a view to promoting early recovery of patients, early withdrawal of ventilator-assisted ventilation, shortening ECMO auxiliary time, improving patients' exercise level and respiratory function, reducing complications, and improving the quality of near-term and long-term survival.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-contemporaneous control
| Arm | Type | Receives |
|---|---|---|
| routine treatment | Placebo comparator | Behavioral: routine treatmentReview the collection of patient-related clinical data, collation of clinical data and outcome indicators |
| Experimental group | Experimental | Behavioral: early physiotherapy programsImplement early physiotherapy programs. The early physiotherapy program for VV-ECMO patients mainly includes the establishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- VV-ECMO assisted support
- lung failure (e.g. ARDS)
- age ≥18 years
- sober
- informed consent to this study
Key exclusion criteria (5 listed)
- unstable blood flow mechanics
- active bleeding
- mental disorders that do not work together
- people waiting for lung transplants
- people at the end of life (e.g. advanced lung cancer)
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 |
|---|---|---|
| early physiotherapy programsestablishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy | Behavioural | Experimental group |
| routine treatmentprovide routine nursing and rehabilitation program | Behavioural | routine treatment |
Primary outcome
VV-ECMO auxiliary time
Time frame: 1 year
the time for VV-ECMO auxiliary
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- 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.
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 early physiotherapy programs and routine treatment in people with Extracorporeal Membrane Oxygenation Complication, 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 5 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 15 Jul 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?
VV-ECMO auxiliary time (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 15 Jul 2021.