Assessment of the Learning Curve of Total Thoracoscopic Mitral Valve Repair

NCT05106582 | Completed

• 1 other identifier: chinaPLAGH-08983220
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Thoracoscopic Mitral Valve Plasty; Minimally Invasive; Learning Curve

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• data miss greater than 10%

Sponsors & Collaborators

• Yunlong Fan: lead

Study Sites (1)

Chinese PLA General hospital

Beijing, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 3, 2021
• Study Start: October 1, 2017
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

CN (1)