Wounds and InjuriesNCT06339073
CT-based Model for Predicting Prolonged Weaning in Patients With Abdominal Trauma
An observational study of Wounds and Injuries and Ventilation Therapy; Complications, run by Jinling Hospital, China at 1 site in China.
Trial summary
Critically ill patients often require tracheal intubation for mechanical ventilation, and timely weaning is crucial for airway management and reducing complications. However, there is currently a lack of an effective tool to predict weaning time in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Ventilation Therapy; Complications
- What is being tested?
- mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 1,023 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 5 Feb 2024
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with abdominal trauma admitted to the General Surgical Department of Jinling Hospital from January 2010 to April 2023 were screened for eligibility.
Who may be able to join
- (1) with information on survival status and time;
- (2) aged 18-80 years;
- (3) admitted to ICU;
- (4) with abdominal CT performed within 1-week post-trauma;
- (5) use of mechanical ventilation.
Who cannot join
- (1) low-quality CT images;
- (2) history of mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site
the General Surgical Department of Jinling Hospital
Nanjing, Jiangsu, 210002
About this study
Official title: CT-based Model for Predicting Prolonged Weaning From Mechanical Ventilation in Patients With Abdominal Trauma: a Retrospective Cohort Study
Critically ill patients often require tracheal intubation for mechanical ventilation, and timely weaning is crucial for airway management and reducing complications. However, there is currently a lack of an effective tool to predict weaning time in critically ill patients. This retrospective study established an effective nomogram model for predicting the time of weaning from mechanical ventilation in abdominal trauma patients by considering multiple perspectives. The model has been validated and demonstrated good performance in terms of discrimination, calibration, and clinical utility. Moreover, the model can effectively predict the prognosis of critically ill patients. The findings of this study have important implications for guiding respiratory management in clinically critically ill patients, particularly trauma patients.
- Being tested
- mechanical ventilation
- Keywords
- computed tomography, prolonged weaning, ventilation, trauma
- Medical subject headings
- Wounds and Injuries, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical ventilationDevice
Abdominal trauma patients were treated with mechanical ventilation according to their conditions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged mechanical ventilation
Prolonged mechanical ventilation was defined as length of mechanical ventilation >7 days
Measured: through whole hospitalization of each participant, an average of 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Oct 2023
- Primary completion15 Dec 2023
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- 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
- 1,023 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengchan Xi, Nanjing Maternity and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339073
- Sponsor's protocol ID
- 2021NZKY-045-01
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-based Model for Predicting Prolonged Weaning From Mechanical Ventilation in Patients With Abdominal Trauma: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06339073
- Acronym / sponsor ID
- 2021NZKY-045-01
- Keywords
- computed tomography, prolonged weaning, ventilation, trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,023 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 1 Apr 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.
Critically ill patients often require tracheal intubation for mechanical ventilation, and timely weaning is crucial for airway management and reducing complications. However, there is currently a lack of an effective tool to predict weaning time in critically ill patients. This retrospective study established an effective nomogram model for predicting the time of weaning from mechanical ventilation in abdominal trauma patients by considering multiple perspectives. The model has been validated and demonstrated good performance in terms of discrimination, calibration, and clinical utility. Moreover, the model can effectively predict the prognosis of critically ill patients. The findings of this study have important implications for guiding respiratory management in clinically critically ill patients, particularly trauma patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with abdominal trauma admitted to the General Surgical Department of Jinling Hospital from January 2010 to April 2023 were screened for eligibility.
Key inclusion criteria (5 listed)
- (1) with information on survival status and time;
- (2) aged 18-80 years;
- (3) admitted to ICU;
- (4) with abdominal CT performed within 1-week post-trauma;
- (5) use of mechanical ventilation.
Key exclusion criteria (2 listed)
- (1) low-quality CT images;
- (2) history of mental illness.
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 |
|---|---|---|
| mechanical ventilationAbdominal trauma patients were treated with mechanical ventilation according to their conditions. | Device | – |
Primary outcome
Prolonged mechanical ventilation
Time frame: through whole hospitalization of each participant, an average of 25 days
Prolonged mechanical ventilation was defined as length of mechanical ventilation >7 days
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 1 Apr 2024.
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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 Wounds and Injuries and Ventilation Therapy; Complications, run by Jinling Hospital, China 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 5 inclusion and 2 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 1 Apr 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?
Prolonged mechanical ventilation (time frame: through whole hospitalization of each participant, an average of 25 days). 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 1 Apr 2024.