Cross-sectional Survey of Zhejiang ECMO Application

July 15, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mao Zhang, MD
  • Phone Number: ０８６ 5718778465
  • Email: zmhz@hotmail.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital, Zhejiang University School of Medicine & Institute of Emergency Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All general hospitals at the first people's hospital and above at the county and district level in Zhejiang Province

Description

Inclusion Criteria:

  • All general hospitals at the first people's hospital and above at the county and district level in Zhejiang Province

Exclusion Criteria:

  • Hospitals that explicitly do not wish to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
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 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Zhejiang Hospital's Cognitive Status of ECMO Development
Time Frame: 1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
First People's Hospital of Hangzhou
Ningbo Medical Center Lihuili Hospital
Sir Run Run Shaw Hospital
Red Cross Hospital, Hangzhou, China
Zhejiang Provincial People's Hospital
The First Affiliated Hospital of Zhejiang Chinese Medical University
The Affiliated Hospital of Hangzhou Normal University
Zhejiang Hospital
Hangzhou Third People's Hospital
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 Lin'an 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 First People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bin Zhang, masters, Departmental staff

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • I2021001538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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