Assessment of the Learning Curve of Total Thoracoscopic Mitral Valve Repair

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

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.

Study Overview

• Status: Completed
• Conditions: Total Thoracoscopic Mitral Valve Plasty; Minimally Invasive; Learning Curve

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

age over 18 years who underwent total thoracoscopic MVP without concurrent cardiac Surgery

Description

Inclusion Criteria:

• age over 18 years who underwent total thoracoscopic MVP without concurrent cardiac Surgery

Exclusion Criteria:

• data miss greater than 10%

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary bypass (CPB) time	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.	Intra-operative
Aortic clamping (AC) time	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.	Intra-operative

Collaborators and Investigators

• Sponsor: Yunlong Fan

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 30, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 30, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: chinaPLAGH-08983220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No