NomogramADreintubateNCT06415630
Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection
An observational study of Nomogram and Prediction Model, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Nomogram, Prediction Model, Type A Aortic Dissection
- What is being tested?
- Type A aortic dissection surgery
- Type of treatment
- Surgery or procedure
- How many people
- 861 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 90 years
- All sexes
- 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.
Who may be able to join
- patients diagnosed with AAD admitted for open surgery; (2) aged 18 years or older.
Who cannot join
- patients deceased during or within 24 hours after surgery; (2) patients with preoperative intubation.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: Multiple Automated Machine-learning Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection
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.
- Being tested
- Type A aortic dissection surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type A aortic dissection surgeryProcedure or surgery
Patients with type A aortic dissection undergone surgery.
| Study group | Role | What they receive |
|---|---|---|
| training group | 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. Receives: Procedure: Type A aortic dissection surgery | |
| testing group | 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. Receives: Procedure: Type A aortic dissection surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative reintubation
reintubation incidence in patients with type A aortic dissection undergoing surgery
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Jan 2018
- Primary completion31 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NomogramStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 861 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415630
- Sponsor's protocol ID
- WHUH-AADreintu
- Acronym
- ADreintubate
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Automated Machine-learning Prediction Models for Postoperative Reintubation in Patients With Acute Aortic Dissection
- ClinicalTrials.gov ID
- NCT06415630
- Acronym / sponsor ID
- ADreintubate / WHUH-AADreintu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 861 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 May 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | – | Procedure: Type A aortic dissection surgeryTo 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. |
| testing group | – | Procedure: Type A aortic dissection surgeryTesting 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. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (1 listed)
- patients diagnosed with AAD admitted for open surgery; (2) aged 18 years or older.
Key exclusion criteria (1 listed)
- patients deceased during or within 24 hours after surgery; (2) patients with preoperative intubation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type A aortic dissection surgeryPatients with type A aortic dissection undergone surgery. | Procedure or surgery | testing group, training group |
Primary outcome
postoperative reintubation
Time frame: 3 month
reintubation incidence in patients with type A aortic dissection undergoing surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Nomogram and Prediction Model, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 16 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative reintubation (time frame: 3 month). 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 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.