Assessment of the Learning Curve of Total Thoracoscopic Mitral Valve Repair

Total thoracoscopic mitral valve plasty (MVP) is characterized by minimal trauma, minimal bleeding, and short postoperative recovery time. The learning curve of any new procedure needs to be evaluated for learning and replication.Using Cardiopulmonary bypass (CPB) time and Aortic clamping (AC) time as evaluation variables, we visualized the learning curve for total thoracoscopic MVP using Cumulative sum analysis. We also analyzed important postoperative variables such as postoperative drainage, duration of mechanical ventilation, ICU stay and postoperative hospital stay.

The retrospective study comprised 150 consecutive patients who underwent total thoracoscopic MVP from October 2017 to July 2021.

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Key information

Conditions

Total Thoracoscopic Mitral Valve Plasty; Minimally Invasive; Learning Curve

Age range

18 year and older

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 total thoracoscopic MVP 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 total thoracoscopic mitral valve plasty (MVP) 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 total thoracoscopic mitral valve plasty (MVP) 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

Assessment of the Learning Curve of Total Thoracoscopic Mitral Valve Repair Using Cumulative Sum Analysis (CUSUM)

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Nov 3, 2021
Registry last updated: Nov 3, 2021

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

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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.