Completed

NCT Number: NCT05126771

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.

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Key information

Conditions

Cumulative Sum Learning Curves Stanford Type A Aorta Dissection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age over 18 years who underwent surgery for stanford type A aorta dissection without concurrent cardiac Surgery

Exclusion criteria

data miss greater than 10%

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Yunlong Fan

Other

Registry information

Official study title

Using CUSUM to Analyze the Learning Curve of Aortic Arch Replacement Surgery in Chinese Mainland With Stanford Type A Aortic Dissection

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Nov 19, 2021
Registry last updated: Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.