Respiratory Failure Patients Treated With ECMONCT06231446
Extracorporeal Membrane Oxygenation for Respiratory Failure Patients
An observational study of Respiratory Failure Patients Treated With ECMO, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
The present study is a multicentre cohort study. Respiratory failure patients treated with extracorporeal membrane oxygenation (ECMO) were enrolled. Clinical data before and during ECMO treatment were collected. Clinical data before and during ECMO treatment were collected. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Failure Patients Treated With ECMO
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2022to 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Respiratory failure patients with ECMO in China-Japan Friendship Hospital, The First Affiliated Hospital of Anhui Medical University, The Second Affiliated Hospital, Zhejiang University School of Medicine and Jiangxi Provincial People's Hospital.
Who may be able to join
- Age ≥ 18 years and ≤ 80 years.
- The patient or guardian voluntarily signs an informed consent form.
- If one of the following conditions is met.
- ARDS patients: lung-protective ventilation (Vt 6ml/kg, PEEP ≥ 10cm H2O) combined with recruitment maneuver, prone position ventilation, or high frequency oscillation ventilation with PaO2/FiO2<100 mmHg or P(A-a)O2>600 mmHg under pure oxygen inhalation; or respiratory rate>35 breaths/min, pH<7.2 and plateau pressure>30 cmH2O, with VV-ECMO adjuvant therapy.
- Lung transplantation patients with ECMO support during perioperative period.
- Asthma patients: under invasive mechanical ventilation support, platform pressure >35cmH2O concomitant with severe respiratory acidosis (pH<7.1), or unstable hemodynamics, perform VV-ECMO or ECCO2R adjuvant therapy if there is no contraindication to ECMO,
- Chronic Obstructive Pulmonary Disease (COPD): to enable patients with severe COPD requiring invasive ventilation to avoid intubation, or to assist in evacuation of tracheal intubation, perform ECMO adjuvant therapy;.
- Perioperative ECMO support for elective surgeries such as high-risk or complex tracheobronchial surgeries and high-risk or complex pneumonectomies; 6). Patients judged by the investigator to be eligible for this study, such as thoracic surgery patients with high perioperative risk and prophylactic use of ECMO for perioperative safety.
Who cannot join
- Age < 18 years or > 80 years.
- Duration of positive pressure ventilation with tracheal intubation for more than 7 days prior to admission.
- Combination of severe irreversible end-stage disease, such as cancer, end-stage of the hepatocirrhosis, etc.
- Irreversible multiorgan failure.
- Combined cerebrovascular events such as severe cognitive impairment, cerebral haemorrhage or stroke occurring within 3 months.
- Severe coagulopathies or bleeding disorders, or the presence of contraindications to anticoagulation, or inability to administer systemic anticoagulation.
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- Patients who are pregnant or breastfeeding.
- Severe peripheral vascular disease or difficulty with ECMO placement.
- With other untreatable end-stage disease.
- Other inappropriate conditions for this study in the opinion of investigators
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship hospital
Beijing, Beijing Municipality, 100028
Chen Wang, MD
About this study
Official title: A Multicenter Prospective Cohort Study of the Clinical Characteristics and Prognosis of Respiratory Failure Patients With ECMO Therapy
The present study is a multicentre cohort study. Respiratory failure patients treated with extracorporeal membrane oxygenation (ECMO) were enrolled. Clinical data before and during ECMO treatment were collected. Clinical data before and during ECMO treatment were collected. By this retrospective clinical data and prospective study, to observe the current status of respiratory failure patients treated with ECMO in China, analyze the clinical characteristics and prognosis of patients, and explore the clinical prevention and treatment strategies of major complications of ECMO.
Read the detailed description
Extracorporeal membrane oxygenation (ECMO) is the ultimate life support for critically ill patients. However, ECMO was developed relatively late in China, and the large number of applications in the field of respiratory failure originated from the 2009 H1N1 influenza epidemic in China. Since then, the number of respiratory failure patients with ECMO has increased year by year. Nevertheless, there are still many problems about ECMO therapy for respiratory failure in China, mainly as follows:(1) Lack of real-world clinical data on ECMO. Most centers do not have their own databases, lack long-term follow-up, and are unable to establish a mature ECMO quality management system. (2) Lack of ECMO-related biological sample libraries. (3) Risk factors for major complications such as thrombosis and hemorrhage, ventilator-associated pneumonia, and bloodstream infections are still unclear. At present, most of the experience in the prevention and treatment of major complications of ECMO comes from foreign studies, and clinical studies have confirmed that the sensitivity and specificity of the currently commonly used biological indicators in the prediction and early warning of complications are not ideal. Therefore, there is an urgent need to carry out research on new biomarkers based on the establishment of clinical databases and biospecimen libraries. We retrospectively collected clinical data on respiratory failure patients treated with ECMO from June 2019 from five hospitals, and prospectively enrolled respiratory failure patients treated with ECMO from October 2022 from five hospitals. By this cohort study, to establish clinical databases and biospecimen libraries, and analyze the clinical characteristics and prognosis of patients, and explore the clinical prevention and treatment strategies of major complications of ECMO.
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This was an observational cohort study with no intervention for all enrolled patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Measured: 30 days
Secondary outcomes (7)
Duration of mechanical ventilation
Measured: From the onset of endotracheal intubation to the withdrawal of endotracheal intubation or death，an average of 5 weeks.
ECMO duration
Measured: From the onset of ECMO to the withdrawal of ECMO or death, an average of 4 weeks.
Length of stay in ICU
Measured: From ICU admission to ICU discharge or death, an average of 8 weeks.
Systemic and localized bleeding
Measured: From ICU admission to discharge or death, , an average of 8 weeks.
Ventilator-associated pneumonia
Measured: From ECMO run to 48 hours after ECMO withdrawal, an average of 6 weeks.
Catheter-related bloodstream infection
Measured: From ECMO run to 48 hours after ECMO withdrawal, an average of 4 weeks.
ECMO-related thrombosis
Measured: From the onset of ECMO to one week after the withdrawal of ECMO or death, an average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start20 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Failure Patients Treated With ECMOStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingyuan Zhan, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231446
- Sponsor's protocol ID
- 2022-KY-113-1
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Cohort Study of the Clinical Characteristics and Prognosis of Respiratory Failure Patients With ECMO Therapy
- ClinicalTrials.gov ID
- NCT06231446
- Acronym / sponsor ID
- 2022-KY-113-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Jan 2024 (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 present study is a multicentre cohort study. Respiratory failure patients treated with extracorporeal membrane oxygenation (ECMO) were enrolled. Clinical data before and during ECMO treatment were collected. Clinical data before and during ECMO treatment were collected. By this retrospective clinical data and prospective study, to observe the current status of respiratory failure patients treated with ECMO in China, analyze the clinical characteristics and prognosis of patients, and explore the clinical prevention and treatment strategies of major complications of ECMO.
Detailed description
Extracorporeal membrane oxygenation (ECMO) is the ultimate life support for critically ill patients. However, ECMO was developed relatively late in China, and the large number of applications in the field of respiratory failure originated from the 2009 H1N1 influenza epidemic in China. Since then, the number of respiratory failure patients with ECMO has increased year by year. Nevertheless, there are still many problems about ECMO therapy for respiratory failure in China, mainly as follows:(1) Lack of real-world clinical data on ECMO. Most centers do not have their own databases, lack long-term follow-up, and are unable to establish a mature ECMO quality management system. (2) Lack of ECMO-related biological sample libraries. (3) Risk factors for major complications such as thrombosis and hemorrhage, ventilator-associated pneumonia, and bloodstream infections are still unclear. At present, most of the experience in the prevention and treatment of major complications of ECMO comes from foreign studies, and clinical studies have confirmed that the sensitivity and specificity of the currently commonly used biological indicators in the prediction and early warning of complications are not ideal. Therefore, there is an urgent need to carry out research on new biomarkers based on the establishment of clinical databases and biospecimen libraries. We retrospectively collected clinical data on respiratory failure patients treated with ECMO from June 2019 from five hospitals, and prospectively enrolled respiratory failure patients treated with ECMO from October 2022 from five hospitals. By this cohort study, to establish clinical databases and biospecimen libraries, and analyze the clinical characteristics and prognosis of patients, and explore the clinical prevention and treatment strategies of major complications of ECMO.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Respiratory failure patients with ECMO in China-Japan Friendship Hospital, The First Affiliated Hospital of Anhui Medical University, The Second Affiliated Hospital, Zhejiang University School of Medicine and Jiangxi Provincial People's Hospital.
Key inclusion criteria (8 listed)
- Age ≥ 18 years and ≤ 80 years.
- The patient or guardian voluntarily signs an informed consent form.
- If one of the following conditions is met.
Key exclusion criteria (10 listed)
- Age < 18 years or > 80 years.
- Duration of positive pressure ventilation with tracheal intubation for more than 7 days prior to admission.
- Combination of severe irreversible end-stage disease, such as cancer, end-stage of the hepatocirrhosis, etc.
- Irreversible multiorgan failure.
- Combined cerebrovascular events such as severe cognitive impairment, cerebral haemorrhage or stroke occurring within 3 months.
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 |
|---|---|---|
| No interventionThis was an observational cohort study with no intervention for all enrolled patients. | Other | – |
Primary outcome
30-day mortality
Time frame: 30 days
7 secondary outcomes
Duration of mechanical ventilation
Time frame: From the onset of endotracheal intubation to the withdrawal of endotracheal intubation or death，an average of 5 weeks.
ECMO duration
Time frame: From the onset of ECMO to the withdrawal of ECMO or death, an average of 4 weeks.
Length of stay in ICU
Time frame: From ICU admission to ICU discharge or death, an average of 8 weeks.
Systemic and localized bleeding
Time frame: From ICU admission to discharge or death, , an average of 8 weeks.
Ventilator-associated pneumonia
Time frame: From ECMO run to 48 hours after ECMO withdrawal, an average of 6 weeks.
Catheter-related bloodstream infection
Time frame: From ECMO run to 48 hours after ECMO withdrawal, an average of 4 weeks.
ECMO-related thrombosis
Time frame: From the onset of ECMO to one week after the withdrawal of ECMO or death, an average of 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- 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.
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 Respiratory Failure Patients Treated With ECMO, run by China-Japan Friendship Hospital 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 8 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 30 Jan 2024. 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 Zhijiang Qi, Dr (+8618801283217, thymcglqi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: 30 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 30 Jan 2024.