NCT06415630

Brief Summary

Reintubation is an adverse postoperative complication in patients with Type A aortic dissection (AAD) that correlates to poor outcomes. This study aims to analyze the risk factors associated with reintubation and to create a fully automated score model to predict the incidence of reintubation. A total of 861 patients diagnosed with AAD and undergoing surgical procedures in a single institution between January 2018 and October 2023 were selected in wuhan Union Hospital. Preoperative and postoperative informmation was used for seeking risk factors and build prediction model for postoperative reintubation. Finally, 5 risk factors wasidentified and a nomogram was established for predicting postoperative reintubation in patients with AAD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
861

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 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

January 1, 2018

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

5.8 years

First QC Date

May 9, 2024

Last Update Submit

May 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative reintubation

    reintubation incidence in patients with type A aortic dissection undergoing surgery

    3 month

Study Arms (2)

training group

To determine potential predictive factors, the training group was subjected to LASSO regression analysis, which effectively eliminated several irrelevant or multicollinearity independent variables to reduce high-dimensional data.Seven models were initially constructed in the training group: multivariable logistics regression (MLR), decision-tree modeling, random forest, XGBoost, Support Vector Machines, k-nearest neighbors, and LightGBM.

Procedure: Type A aortic dissection surgery

testing group

Testing group was used to examine the performance of the seven prediction models, including discrimination and calibration performance. Finally, the model with best discrimination and calibration performance was used to construct nomogram for predicting reintubation.

Procedure: Type A aortic dissection surgery

Interventions

Patients with type A aortic dissection undergone surgery.

testing grouptraining group

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

A total of 892 patients with AAD who underwent open surgery at Wuhan Union Hospital between January 2018 and October 2023 were enrolled using a convenient sampling method.

You may qualify if:

  • (1) patients diagnosed with AAD admitted for open surgery; (2) aged 18 years or older.

You may not qualify if:

  • (1) patients deceased during or within 24 hours after surgery; (2) patients with preoperative intubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 16, 2024

Study Start

January 1, 2018

Primary Completion

October 31, 2023

Study Completion

December 31, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations