NCT05126771

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

November 6, 2021

Last Update Submit

November 16, 2021

Conditions

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 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.

    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.

    Intra-operative

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

age between 18 years and 65 years who underwent standford type A aorta dissection

You may qualify if:

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

You may not qualify if:

  • data miss greater than 10%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General hospital

Beijing, China

Location

Study Design

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

Study Record Dates

First Submitted

November 6, 2021

First Posted

November 19, 2021

Study Start

September 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations