Extracorporeal Membrane OxygenationNCT05083624
Feasibility and Prognosis of Early Rehabilitation in Patients With ECMO
A study testing rehabilation therapy in people with Extracorporeal Membrane Oxygenation, run by JinyanXing at 1 site in China.
Trial summary
ECMO is increasingly used in critically ill patients with severe circulatory and/or respiratory failure. Because of the catheterization of the femoral artery and femoral vein, usage of sedatives, and occasionally with neuromuscular blockers, ECMO patients are generally considered unsuitable for early activity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation
- What is being tested?
- rehabilation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 Nov 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECMO time ≥1 day
- Aged older than16 years old and less than 70 years old
Who cannot join
- coma deep
- sedation muscle relaxation (RAAS-3-5)
- Active bleeding deep vein thrombosis
- High dose of vasoactive drugs
- unstable vital signs
- Acute stage of myocardial infarction (within 2d)
- Malignant arrhythmia
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266555
About this study
Official title: Feasibility and Prognosis of Early Rehabilitation in Patients With Extracorporeal Membrane Oxygenation
ECMO is increasingly used in critically ill patients with severe circulatory and/or respiratory failure. Because of the catheterization of the femoral artery and femoral vein, usage of sedatives, and occasionally with neuromuscular blockers, ECMO patients are generally considered unsuitable for early activity. However, some recent retrospective studies and a small number of single-center, small-scale prospective studies have shown that early activity of ECMO patients is feasible, and early active activity is associated with recovery of independent function and reduction of delirium incidence.
- Conditions
- Extracorporeal Membrane Oxygenation
- Being tested
- rehabilation therapy
- Keywords
- Extracorporeal Membrane Oxygenation, early rehabilation, muscle ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilation therapyBehavioural
After comprehensive assessment by doctors, nurses and rehabilitation therapists, patients gradually begin rehabilitation treatment.IMS 0: no mobilisation or passively exercised by staff. IMS 1: sitting in bed and actively exercising .IMS 2: passively moved to chair without standing.IMS 3: sitting over edge of bed.IMS 4: standing in front of bed.IMS 5: transferring bed to chair.IMS 6: marching on spot.IMS 7: walking with assistance of more than one person.IMS 8: walking with assistance of one person.IMS 9: walking independently with a gait aid.IMS 10: walking independently without a gait aid.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation group | Experimental | Not described Receives: Behavioral: rehabilation therapy |
| control group | No intervention | adhere to standardized management guidelines for anticoagulation, ventilation, sedation specific to the MICU ECMO population |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle ultrasound
The thickness of intercostal muscle and rectus femoris muscle was measured by ultrasound
Measured: 7 days
Secondary outcomes (1)
ECMO duration time
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 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 OxygenationStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JinyanXing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JinyanXing, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083624
- Sponsor's protocol ID
- QYFYKYLL9121011920
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Prognosis of Early Rehabilitation in Patients With Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT05083624
- Acronym / sponsor ID
- QYFYKYLL9121011920
- Conditions
- Extracorporeal Membrane Oxygenation
- Keywords
- Extracorporeal Membrane Oxygenation, early rehabilation, muscle ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- JinyanXingUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 19 Oct 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.
ECMO is increasingly used in critically ill patients with severe circulatory and/or respiratory failure. Because of the catheterization of the femoral artery and femoral vein, usage of sedatives, and occasionally with neuromuscular blockers, ECMO patients are generally considered unsuitable for early activity. However, some recent retrospective studies and a small number of single-center, small-scale prospective studies have shown that early activity of ECMO patients is feasible, and early active activity is associated with recovery of independent function and reduction of delirium incidence.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation group | Experimental | Behavioral: rehabilation therapy |
| control group | No intervention | –adhere to standardized management guidelines for anticoagulation, ventilation, sedation specific to the MICU ECMO population |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ECMO time ≥1 day
- Aged older than16 years old and less than 70 years old
Key exclusion criteria (8 listed)
- coma deep
- sedation muscle relaxation (RAAS-3-5)
- Active bleeding deep vein thrombosis
- High dose of vasoactive drugs
- unstable vital signs
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 |
|---|---|---|
| rehabilation therapyAfter comprehensive assessment by doctors, nurses and rehabilitation therapists, patients gradually begin rehabilitation treatment.IMS 0: no mobilisation or passively exercised by staff. IMS 1: sitting in bed and actively exercising .IMS 2: passively moved to chair without standing.IMS 3: sitting over edge of bed.IMS 4: standing in front of bed.IMS 5: transferring bed to chair.IMS 6: marching on spot.IMS 7: walking with assistance of more than one person.IMS 8: walking with assistance of one person.IMS 9: walking independently with a gait aid.IMS 10: walking independently without a gait aid. | Behavioural | Rehabilitation group |
Primary outcome
muscle ultrasound
Time frame: 7 days
The thickness of intercostal muscle and rectus femoris muscle was measured by ultrasound
1 secondary outcome
ECMO duration time
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Diagnosis of ECMO Cannula Infection: Prospective Comparison of Sampling Methods
ECMO Cannula Infection, Extracorporeal Membrane Oxygenation Complication
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Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
Not yet recruitingPhase 1/2
PACE: Prostacyclin AntiCoagulation in ECMO
ECMO
RecruitingObservational study
Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support
Drug Effect
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?
A study testing rehabilation therapy in people with Extracorporeal Membrane Oxygenation, run by JinyanXing 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 2 inclusion and 8 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 19 Oct 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. 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 Jinyan Xing, Doctor (86-0532-82919386 ext. 82919386, xingjy@qdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle ultrasound (time frame: 7 days). 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 19 Oct 2021.