Acute Type A Aortic DissectionNCT06929780
A Prediction Model of Prolonged Mechanical Ventilation Following Acute Type A Aortic Dissection Surgery
An observational study of Acute Type A Aortic Dissection, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. To validate the predictive performance of the model for PMV after ATAAD surgery 2. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Acute Type A Aortic Dissection
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Study population: ATAAD postoperative patients admitted to SICU
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital
Beijing, Beijing Municipality, 100029
Zhou Xiaoming, 010-68314466, zhouxmcmu@163.com
About this study
Official title: 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:
- To validate the predictive performance of the model for PMV after ATAAD surgery
- To assess the proportion of PMV among patients undergoing ATAAD surgery
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 72 hours after ATAAD surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: 30 days after ATAAD surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Hou, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929780
- Sponsor's protocol ID
- 2025-zxm-01
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Mechanical Ventilation Following Acute Type A Aortic Dissection Surgery: Risk Factor Analysis, Impact on Clinical Outcomes and Development of Prediction Model
- ClinicalTrials.gov ID
- NCT06929780
- Acronym / sponsor ID
- 2025-zxm-01
- Conditions
- Acute Type A Aortic Dissection
- Keywords
- Acute type A aortic dissection, Prolonged mechanical ventilation, mechanical ventilation time
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To validate the predictive performance of the model for PMV after ATAAD surgery
- To assess the proportion of PMV among patients undergoing ATAAD surgery
- To evaluate the ICU length of stay and operative mortality in patients with PMV following ATAAD surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ATAAD postoperative patients admitted to SICU
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
2 secondary outcomes
ICU length of stay (ICU-LOS)
Time frame: From surgery to discharge or death, whichever came first, assessed up to 6 months
surgery-related mortality
Time frame: 30 days after ATAAD surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Type A Aortic Dissection, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhou Xiaoming, Dr (010-68314466, zhouxmcmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.