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

April 8, 2025 updated by: Gang Hou, China-Japan Friendship Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Fuwai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 72 hours after 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
Time Frame: 72 hours after ATAAD surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ICU length of stay (ICU-LOS)
Time Frame: From surgery to discharge or death, whichever came first, assessed up to 6 months
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
Time Frame: 30 days after ATAAD surgery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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