## Protocol Section
### Identification Module
**NCT ID:** NCT06415630

**Acronym:** ADreintubate

**Brief Title:** Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection

**Official Title:** Multiple Automated Machine-learning Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection

#### Organization Study ID Info
**ID:** WHUH-AADreintu
#### Organization
**Class:** OTHER
**Full Name:** Wuhan Union Hospital, China
### Status Module
#### Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-10-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wuhan Union Hospital, China

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Nomogram

- Prediction Model

- Type A Aortic Dissection

- Postoperative Reintubation

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 861

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Type A aortic dissection surgery

**Label:** training group

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Procedure: Type A aortic dissection surgery

**Label:** testing group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- testing group

- training group

**Description:** Patients with type A aortic dissection undergone surgery.

**Name:** Type A aortic dissection surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** reintubation incidence in patients with type A aortic dissection undergoing surgery

**Measure:** postoperative reintubation

**Time Frame:** 3 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

Exclusion Criteria:

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

**Maximum Age:** 90 Years

**Minimum Age:** 19 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Wuhan

**Country:** China

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

**State:** Hubei

**Zip:** 430022

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000094665

- Term: Dissection, Blood Vessel

- ID: D000000783

- Term: Aneurysm

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000094683

- Term: Acute Aortic Syndrome

- ID: D000001018

- Term: Aortic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4114

- Name: Aortic Dissection

- Relevance: HIGH

- As Found: Aortic Dissection

- ID: M3081

- Name: Dissection, Blood Vessel

- Relevance: LOW

- As Found: Unknown

- ID: M4113

- Name: Aneurysm

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M3085

- Name: Acute Aortic Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M4334

- Name: Aortic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000784

- Term: Aortic Dissection

### Misc Info Module

- Version Holder: 2024-05-31
