A Prediction Model of Prolonged Mechanical Ventilation Following Acute Type A Aortic Dissection Surgery

Prolonged Mechanical Ventilation Following Acute Type A Aortic Dissection Surgery: Risk Factor Analysis, Impact on Clinical Outcomes and Development of Prediction Model

The goal of this observational study is to develop and validate a predictive model for prolonged mechanical ventilation (PMV) following acute type A aortic dissection (ATAAD) surgery.

The main questions it aims to answer are:

1. To validate the predictive performance of the model for PMV after ATAAD surgery
2. To assess the proportion of PMV among patients undergoing ATAAD surgery
3. To evaluate the ICU length of stay and operative mortality in patients with PMV following ATAAD surgery

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Type A Aortic Dissection

• Study Type: Observational
• Enrollment (Estimated): 1400

Contacts and Locations

• Study Contact: Name: Zhou Xiaoming, Dr; Phone Number: 010-68314466; Email: zhouxmcmu@163.com
• Study Contact Backup: Name: Zhang Qin, Dr; Phone Number: +86 18990236167; Email: zhangqincmu@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Fuwai Hospital
      • Contact: Zhou Xiaoming; Phone Number: 010-68314466; Email: zhouxmcmu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ATAAD postoperative patients admitted to SICU

Description

Inclusion Criteria:

• Age ≥18 years;
• Diagnosis of acute type A aortic dissection (ATAAD) confirmed by computed tomography angiography and echocardiography;
• Patients who underwent aortic surgery requiring cardiopulmonary bypass (CPB), were admitted to the surgical intensive care unit (SICU), and received mechanical ventilation.

Exclusion Criteria:

• Reintubation;
• Intraoperative death or failure to survive beyond 72 hours postoperatively;
• Pregnancy;
• Severe comorbidities (e.g., lung cancer);
• Missing critical outcome data (e.g., short-term mortality, mechanical ventilation duration, reintubation).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Development cohort; As the development cohort, this cohort retrospectively enrolled approximately 1000 postoperative patients undergoing acute type A aortic dissection (ATAAD) surgery to establish a clinical model for predicting the risk of prolonged mechanical ventilation (PMV) after ATAAD surgery.This cohort will also be utilized to analyze the risk factors for PMV following ATAAD surgery and their impact on clinical outcomes.
Validation cohort; As the validation cohort, this cohort retrospectively enrolled approximately 400 patients (from January 2024 to December 2024) who underwent ATAAD surgery to validate the predictive performance of the model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The predictive performance of the model for prolonged mechanical ventilation (PMV) following acute type A aortic dissection (ATAAD) surgery	The predictive performance of PMV following ATAAD surgery includes its discriminative ability and calibration ablility.	72 hours after ATAAD surgery
The proportion of patients with PMV	The proportion of patients with PMV refers to the proportion of patients with PMV among the total included ATAAD postoperative patients. PMV is defined as postoperative mechanical ventilation lasting more than 72 hours	72 hours after ATAAD surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay (ICU-LOS)	ICU length of stay was defined as the length of time spent in ICU from surgery to discharge or death.	From surgery to discharge or death, whichever came first, assessed up to 6 months
surgery-related mortality	surgery-related mortality encompassed any death occurring during the index hospitalization (even beyond 30 days) or after discharge but before postoperative day 30.	30 days after ATAAD surgery

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Prolonged mechanical ventilation; Acute type A aortic dissection; mechanical ventilation time
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: 2025-zxm-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No