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

NCT06929780 | Not Yet Recruiting DMC

• 1 other identifier: 2025-zxm-01
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Type A Aortic Dissection

Keywords

Acute type A aortic dissection; Prolonged mechanical ventilation; mechanical ventilation time

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• ICU length of stay (ICU-LOS)

  From surgery to discharge or death, whichever came first, assessed up to 6 months

• surgery-related mortality

  30 days after ATAAD surgery

Study Arms (2)

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.

Eligibility Criteria

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

Study Population

ATAAD postoperative patients admitted to SICU

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100029, China

Location

Central Study Contacts

Zhou Xiaoming, Dr

CONTACT

010-68314466; zhouxmcmu@163.com

Zhang Qin, Dr

CONTACT

+86 18990236167; zhangqincmu@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 16, 2025
• Study Start: April 10, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)