Respiratory and Circulation FailureNCT05024786
The Effect of CQI on the Outcome of Patients Supported With ECMO
An observational study of Respiratory and Circulation Failure, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This was a prospective observational study in comparison with a retrospective control group(Jan 2015 to Jun 2019). Two ICUs in China were included. The continuous quality improvement (CQI)strategies were implemented from Jul 2019 to Jun 2021(CQI group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory and Circulation Failure
- What is being tested?
- continuous quality improvements
- How many people
- 163 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old who received ECMO support in the centers between January 2015 and April 2021 were included, not including patients waiting for transplantation with ECMO.
Who may be able to join
- Patients over 18 years old who received ECMO support in the centers
Who cannot join
- patients waiting for transplantation with ECMO.
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: The Effect of Continuous Quality Improvement on the Outcome of Patients Supported With Extracorporeal Membrane Oxygenation in ICU
This was a prospective observational study in comparison with a retrospective control group(Jan 2015 to Jun 2019). Two ICUs in China were included. The continuous quality improvement (CQI)strategies were implemented from Jul 2019 to Jun 2021(CQI group). The mortalities of ECMO patients was compared between the CQI group and the control group.
- Conditions
- Respiratory and Circulation Failure
- Being tested
- continuous quality improvements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous quality improvementsOther
We implement the continuous quality improvement strategy in CQI group, and observe the effect of the strategy on the mortality of patients supported with ECMO .
| Study group | Role | What they receive |
|---|---|---|
| control group | Not described | |
| CQI group | Not described Receives: Other: continuous quality improvements |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mortality of patients supported with ECMO
Measured: January, 2021 to July, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Jul 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory and Circulation FailureStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JinyanXing, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024786
- Sponsor's protocol ID
- QYFYKYLL931311921
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jing Y, Yuan Z, Zhou W, Han X, Qi Q, Song K, Xing J. A phased intervention bundle to decrease the mortality of patients with extracorporeal membrane oxygenation in intensive care unit. Front Med (Lausanne). 2022 Oct 17;9:1005162. doi: 10.3389/fmed.2022.1005162. eCollection 2022.
PubMed 36325385
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Quality Improvement on the Outcome of Patients Supported With Extracorporeal Membrane Oxygenation in ICU
- ClinicalTrials.gov ID
- NCT05024786
- Acronym / sponsor ID
- QYFYKYLL931311921
- Conditions
- Respiratory and Circulation Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 Aug 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.
This was a prospective observational study in comparison with a retrospective control group(Jan 2015 to Jun 2019). Two ICUs in China were included. The continuous quality improvement (CQI)strategies were implemented from Jul 2019 to Jun 2021(CQI group). The mortalities of ECMO patients was compared between the CQI group and the control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | – |
| CQI group | – | Other: continuous quality improvements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old who received ECMO support in the centers between January 2015 and April 2021 were included, not including patients waiting for transplantation with ECMO.
Key inclusion criteria (1 listed)
- Patients over 18 years old who received ECMO support in the centers
Key exclusion criteria (1 listed)
- patients waiting for transplantation with ECMO.
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 |
|---|---|---|
| continuous quality improvementsWe implement the continuous quality improvement strategy in CQI group, and observe the effect of the strategy on the mortality of patients supported with ECMO . | Other | CQI group |
Primary outcome
The mortality of patients supported with ECMO
Time frame: January, 2021 to July, 2021
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 27 Aug 2021.
- Derived from this study: PubMed 36325385Jing Y, Yuan Z, Zhou W, Han X, Qi Q, Song K, Xing J. A phased intervention bundle to decrease the mortality of patients with extracorporeal membrane oxygenation in intensive care unit. Front Med (Lausanne). 2022 Oct 17;9:1005162. doi: 10.3389/fmed.2022.1005162. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Respiratory and Circulation Failure, run by The Affiliated Hospital of Qingdao University 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: finished, as of the sponsor's last update on 27 Aug 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?
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?
The mortality of patients supported with ECMO (time frame: January, 2021 to July, 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05024786, which also lists 1 linked publication.
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 27 Aug 2021.