Cumulative Sum Learning CurvesNCT05126771
Learning Curve of Aortic Arch Replacement Surgery in Chinese Mainland With Stanford Type A Aortic Dissection
An observational study of Cumulative Sum Learning Curves and Stanford Type A Aorta Dissection, run by Yunlong Fan at 1 site in China.
Trial summary
stanford type A aortic dissection is the most common cause of death caused by aortic disease in Chinese mainland. Patients who are hospitalized need immediate surgical treatment.Emergency aortic arch replacement is difficult and risky. Different surgical methods have different effects on postoperative prognosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cumulative Sum Learning Curves, Stanford Type A Aorta Dissection
- How many people
- 139 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: age between 18 years and 65 years who underwent standford type A aorta dissection
Who may be able to join
- age over 18 years who underwent surgery for stanford type A aorta dissection without concurrent cardiac Surgery
Who cannot join
- data miss greater than 10%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using CUSUM to Analyze the Learning Curve of Aortic Arch Replacement Surgery in Chinese Mainland With Stanford Type A Aortic Dissection
stanford type A aortic dissection is the most common cause of death caused by aortic disease in Chinese mainland. Patients who are hospitalized need immediate surgical treatment.Emergency aortic arch replacement is difficult and risky. Different surgical methods have different effects on postoperative prognosis. Aortic arch replacement is divided into total-arch replacement (Sun's operation) and hemi-arch replacement. In this study, and the learning Curve of Aortic Arch Replacement Surgery was evaluated with cumulative cum curve.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary bypass (CPB) time
Cardiopulmonary bypass (CPB) time was used as the main variables for evaluation and visualization of the aorta dissection surgery learning curve using Cumulative sum.Cumulative sum (CUSUM) is a statistical method that focuses on results rather than on the process of performing a program skills, it generates graphs that allow for quick detection of deviations from pre-established standards and is an alternative tool that can be used to evaluate the performance of individual program. CUSUM can be generated based on set acceptable and unacceptable failure rates and the degree to which type 1(α) and type 2(β) errors (false positive and false negative errors) will be tolerated. CUSUM was defined as Sn = ∑(Xi -p0), where Xi = 0 for success and Xi = 1 for failure, p0 is the target reference.
Measured: Intra-operative
Aortic clamping (AC) time
Aortic clamping (AC) time was used as the main variables for evaluation and visualization of the aorta dissection surgery learning curve using Cumulative sum.Cumulative sum (CUSUM) is a statistical method that focuses on results rather than on the process of performing a program skills, it generates graphs that allow for quick detection of deviations from pre-established standards and is an alternative tool that can be used to evaluate the performance of individual program. CUSUM can be generated based on set acceptable and unacceptable failure rates and the degree to which type 1(α) and type 2(β) errors (false positive and false negative errors) will be tolerated. CUSUM was defined as Sn = ∑(Xi -p0), where Xi = 0 for success and Xi = 1 for failure, p0 is the target reference.
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Sep 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cumulative Sum Learning CurvesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yunlong Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunlong Fan, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126771
- Sponsor's protocol ID
- chinaPLAGH-66936549
- Status last verified
- Nov 2021
- First submitted
- 6 Nov 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using CUSUM to Analyze the Learning Curve of Aortic Arch Replacement Surgery in Chinese Mainland With Stanford Type A Aortic Dissection
- ClinicalTrials.gov ID
- NCT05126771
- Acronym / sponsor ID
- chinaPLAGH-66936549
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Yunlong FanUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 19 Nov 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.
stanford type A aortic dissection is the most common cause of death caused by aortic disease in Chinese mainland. Patients who are hospitalized need immediate surgical treatment.Emergency aortic arch replacement is difficult and risky. Different surgical methods have different effects on postoperative prognosis. Aortic arch replacement is divided into total-arch replacement (Sun's operation) and hemi-arch replacement. In this study, and the learning Curve of Aortic Arch Replacement Surgery was evaluated with cumulative cum curve.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- age between 18 years and 65 years who underwent standford type A aorta dissection
Key inclusion criteria (1 listed)
- age over 18 years who underwent surgery for stanford type A aorta dissection without concurrent cardiac Surgery
Key exclusion criteria (1 listed)
- data miss greater than 10%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiopulmonary bypass (CPB) time
Time frame: Intra-operative
Cardiopulmonary bypass (CPB) time was used as the main variables for evaluation and visualization of the aorta dissection surgery learning curve using Cumulative sum.Cumulative sum (CUSUM) is a statistical method that focuses on results rather than on the process of performing a program skills, it generates graphs that allow for quick detection of deviations from pre-established standards and is an alternative tool that can be used to evaluate the performance of individual program. CUSUM can be generated based on set acceptable and unacceptable failure rates and the degree to which type 1(α) and type 2(β) errors (false positive and false negative errors) will be tolerated. CUSUM was defined as Sn = ∑(Xi -p0), where Xi = 0 for success and Xi = 1 for failure, p0 is the target reference.
Aortic clamping (AC) time
Time frame: Intra-operative
Aortic clamping (AC) time was used as the main variables for evaluation and visualization of the aorta dissection surgery learning curve using Cumulative sum.Cumulative sum (CUSUM) is a statistical method that focuses on results rather than on the process of performing a program skills, it generates graphs that allow for quick detection of deviations from pre-established standards and is an alternative tool that can be used to evaluate the performance of individual program. CUSUM can be generated based on set acceptable and unacceptable failure rates and the degree to which type 1(α) and type 2(β) errors (false positive and false negative errors) will be tolerated. CUSUM was defined as Sn = ∑(Xi -p0), where Xi = 0 for success and Xi = 1 for failure, p0 is the target reference.
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 19 Nov 2021.
- 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 Cumulative Sum Learning Curves and Stanford Type A Aorta Dissection, run by Yunlong Fan 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 19 Nov 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?
Cardiopulmonary bypass (CPB) time (time frame: Intra-operative). The study lists 2 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 19 Nov 2021.