Respiration FailureNCT07800325
The Safety and Efficacy of ECMO in the Management of Patients With Respiratory Failure
A study testing ECMO in people with Respiration Failure, run by Life Shield Medical Technology Co., LTD at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of the Rengine extracorporeal cardiopulmonary support system and the ECMO sterile oxygenator in the management of respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration Failure
- What is being tested?
- ECMO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 4 Apr 2026
- 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 ≥18, male or female;
- Patients with respiratory failure and high Paco2, PH < 7.35；
- Researchers believe that this product is beneficial for patients undergoing treatment, such as patients with invasive ventilator weaning difficulty, large airway obstruction, etc；
- Patients or guardians provided written informed consent voluntarily.
Who cannot join
- Oxygenation index <80mmHg;
- Intracranial hemorrhage or severe irreversible brain injury;
- Thrombocytopenia;
- Patients with malignant tumors (expected survival time <1 year);
- patients unable to receive systemic anticoagulation;
- Obesity: BMI>40kg/m2;
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- Those with a history of mental illness who were unable to cooperate in completing the trial;
- During pregnancy and lactation;
- Patients with allergic or severe allergic constitution to the test equipment;
- Participated in other interventional device clinical trials within 3 months before this trial
- Those who were deemed unsuitable to participate in the trial by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 102300
About this study
Evaluation of the efficacy and safety of the Rengine extracorporeal cardiopulmonary support system and the ECMO sterile oxygenator in the management of respiratory failure.
- Conditions
- Respiration Failure
- Being tested
- ECMO
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMOOther
Using ECMO in the management of respiratory failure
| Study group | Role | What they receive |
|---|---|---|
| ECMO | Experimental | Using ECMO in the management of respiratory failure Receives: Other: ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
Measured: Day 7 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Dec 2024
- Primary completion4 Apr 2026
- Study completion4 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration FailureStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life Shield Medical Technology Co., LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800325
- Sponsor's protocol ID
- ECCO2R
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of ECMO in the Management of Patients With Respiratory Failure
- ClinicalTrials.gov ID
- NCT07800325
- Acronym / sponsor ID
- ECCO2R
- Conditions
- Respiration Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Life Shield Medical Technology Co., LTDUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 4 Apr 2026 (actual)
- Study completion
- 4 Apr 2026 (actual)
- First posted
- 2 Sep 2026 (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.
Evaluation of the efficacy and safety of the Rengine extracorporeal cardiopulmonary support system and the ECMO sterile oxygenator in the management of respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO | Experimental | Other: ECMOUsing ECMO in the management of respiratory failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18, male or female;
- Patients with respiratory failure and high Paco2, PH < 7.35；
- Researchers believe that this product is beneficial for patients undergoing treatment, such as patients with invasive ventilator weaning difficulty, large airway obstruction, etc；
- Patients or guardians provided written informed consent voluntarily.
Key exclusion criteria (11 listed)
- Oxygenation index <80mmHg;
- Intracranial hemorrhage or severe irreversible brain injury;
- Thrombocytopenia;
- Patients with malignant tumors (expected survival time <1 year);
- patients unable to receive systemic anticoagulation;
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 |
|---|---|---|
| ECMOUsing ECMO in the management of respiratory failure | Other | ECMO |
Primary outcome
survival
Time frame: Day 7 post-treatment
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 2 Sep 2026.
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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 ECMO in people with Respiration Failure, run by Life Shield Medical Technology Co., LTD 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 4 inclusion and 11 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 2 Sep 2026. 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?
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?
survival (time frame: Day 7 post-treatment). 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 2 Sep 2026.