Extracorporeal Membrane OxygenationNCT04979325
Cross-sectional Survey of Zhejiang ECMO Application
An observational study of Extracorporeal Membrane Oxygenation and Cardiopulmonary Resuscitation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Extracorporeal lung oxygenation (ECMO) was first used in neonates in the 1970s and is now widely used to treat adult patients with intractable shock and respiratory failure who have failed various types of conventional life support. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Cardiopulmonary Resuscitation, Epidemiology
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Sep 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All general hospitals at the first people's hospital and above at the county and district level in Zhejiang Province
Who may be able to join
- All general hospitals at the first people's hospital and above at the county and district level in Zhejiang Province
Who cannot join
- Hospitals that explicitly do not wish to participate
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Official title: A Study on the Application Status of Extracorporeal Membrane Oxygenation (ECMO) in Zhejiang Province
Extracorporeal lung oxygenation (ECMO) was first used in neonates in the 1970s and is now widely used to treat adult patients with intractable shock and respiratory failure who have failed various types of conventional life support. According to the Extracorporeal Life Support Organization (ELSO), a total of 61,193 adult patients worldwide received ECMO in 2019. According to the Extracorporeal Life Support Organization (ELSO), a total of 61,193 adult patients were treated with ECMO worldwide in 2019, including 25,631 VV-ECOM, 12,836 VA, and 5086 ECPR. The number of ECMO cases and hospitals in Zhejiang province are increasing year by year, and they play an irreplaceable role in various critical care resuscitation, especially in response to public emergencies, but there is a lack of precise data on the current status of ECMO implementation. This study aims to investigate the implementation of ECMO, problems and needs of hospitals at all levels in Zhejiang Province, and provide reference for further improving the capacity and quality of ECMO application in the province.
Read the detailed description
This is a multicenter cross-sectional survey study ,was conducted jointly by the Zhejiang Emergency Medicine Quality Control Center, the Zhejiang Medical Emergency Medicine Branch and the Zhejiang Physicians Association Emergency Physicians Branch. The survey covers the general situation and ECMO implementation in general public hospitals at the county and district level in Zhejiang Province, including people's hospitals, Chinese medicine hospitals and above.
- Keywords
- Extracorporeal membrane oxygenation, Epidemiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Contains the general description of the hospital
including hospital level, nature, number of approved beds, total number of outpatient and emergency departments in 2019, number of discharges, and number of operations
Measured: 1 year
ECMO configuration
ECMO equipment manufacturers, models, number of ECMOs, belonging departments, and those who are proficient in ECMO Health care team
Measured: 1 year
ECMO development status
first case development time, independent hospital development time, number, type and number of weaning machines carried out in 2019, operating costs, etc
Measured: 1 year
Secondary outcomes (1)
Zhejiang Hospital's Cognitive Status of ECMO Development
The surveyed unit's views on ECMO's role in hospitals, discipline development and the rescue of critically ill patients, the main difficulties encountered in carrying out ECMO, and the need for ECMO training and quality control
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 posted28 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion1 Sep 2021 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital, Zhejiang Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, First People's Hospital of Hangzhou, The Affiliated Hospital of Hangzhou Normal University, The Third People's Hospital of Hangzhou, Red Cross Hospital, Hangzhou, China, Hangzhou Children's Hospital, The First Hospital of Fuyang District, Hangzhou, The First Hospital of Xiaoshan District, Hangzhou, The First Hospital of Linping District, Hangzhou, The First Hospital of Tonglu County, Hangzhou, The First Hospital of Jiande County, Hangzhou, The First Hospital of Chun'an County, Hangzhou, Affiliated Cixi Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Ningbo First People's Hospital
- Responsible party
- Sponsor
- Investigators
- Bin Zhang, masters, Principal investigator, Departmental staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979325
- Sponsor's protocol ID
- I2021001538
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 28 Jul 2021
- 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 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Application Status of Extracorporeal Membrane Oxygenation (ECMO) in Zhejiang Province
- ClinicalTrials.gov ID
- NCT04979325
- Acronym / sponsor ID
- I2021001538
- Keywords
- Extracorporeal membrane oxygenation, Epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital, Zhejiang Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University, First People's Hospital of Hangzhou, The Affiliated Hospital of Hangzhou Normal University, The Third People's Hospital of Hangzhou, Red Cross Hospital, Hangzhou, China, Hangzhou Children's Hospital, The First Hospital of Fuyang District, Hangzhou, The First Hospital of Xiaoshan District, Hangzhou, The First Hospital of Linping District, Hangzhou, The First Hospital of Tonglu County, Hangzhou, The First Hospital of Jiande County, Hangzhou, The First Hospital of Chun'an County, Hangzhou, Affiliated Cixi Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital, Ningbo First People's Hospital
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 28 Jul 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.
Extracorporeal lung oxygenation (ECMO) was first used in neonates in the 1970s and is now widely used to treat adult patients with intractable shock and respiratory failure who have failed various types of conventional life support. According to the Extracorporeal Life Support Organization (ELSO), a total of 61,193 adult patients worldwide received ECMO in 2019. According to the Extracorporeal Life Support Organization (ELSO), a total of 61,193 adult patients were treated with ECMO worldwide in 2019, including 25,631 VV-ECOM, 12,836 VA, and 5086 ECPR. The number of ECMO cases and hospitals in Zhejiang province are increasing year by year, and they play an irreplaceable role in various critical care resuscitation, especially in response to public emergencies, but there is a lack of precise data on the current status of ECMO implementation. This study aims to investigate the implementation of ECMO, problems and needs of hospitals at all levels in Zhejiang Province, and provide reference for further improving the capacity and quality of ECMO application in the province.
Detailed description
This is a multicenter cross-sectional survey study ,was conducted jointly by the Zhejiang Emergency Medicine Quality Control Center, the Zhejiang Medical Emergency Medicine Branch and the Zhejiang Physicians Association Emergency Physicians Branch. The survey covers the general situation and ECMO implementation in general public hospitals at the county and district level in Zhejiang Province, including people's hospitals, Chinese medicine hospitals and above.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All general hospitals at the first people's hospital and above at the county and district level in Zhejiang Province
Key inclusion criteria (1 listed)
- All general hospitals at the first people's hospital and above at the county and district level in Zhejiang Province
Key exclusion criteria (1 listed)
- Hospitals that explicitly do not wish to participate
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 |
|---|---|---|
| Other | – |
Primary outcome
Contains the general description of the hospital
Time frame: 1 year
including hospital level, nature, number of approved beds, total number of outpatient and emergency departments in 2019, number of discharges, and number of operations
ECMO configuration
Time frame: 1 year
ECMO equipment manufacturers, models, number of ECMOs, belonging departments, and those who are proficient in ECMO Health care team
ECMO development status
Time frame: 1 year
first case development time, independent hospital development time, number, type and number of weaning machines carried out in 2019, operating costs, etc
1 secondary outcome
Zhejiang Hospital's Cognitive Status of ECMO Development
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Bin Zhang, masters principal investigator
Departmental staff
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 Extracorporeal Membrane Oxygenation and Cardiopulmonary Resuscitation, 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 1 inclusion and 1 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 28 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. 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 Mao Zhang, MD (5718778465 ext. ０８６, zmhz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contains the general description of the hospital (time frame: 1 year). The study lists 3 primary outcomes in all. 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 28 Jul 2021.