Pulmonary Contusion , Chest Trauma , Prediction ModelNCT04518904
Establishment of a Prognosis Prediction Model and Scoring Criteria of Pulmonary Contusion Caused by Severe Thoracic Trauma
An observational study of Pulmonary Contusion , Chest Trauma , Prediction Model, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
Trial summary
Pulmonary contusion caused by severe thoracic trauma is a complex disease. Some patients may be secondary to severe complications such as pulmonary infection or even acute respiratory distress syndrome. At present, there have been no reports on related studies based on Chinese population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Contusion , Chest Trauma , Prediction Model
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Jun 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 800 cases of patients were hospitalized from 2014 to 2019.All patients were Chinese.
Who may be able to join
- Chinese patients aged 18 to 80 years,severe chest trauma (flail chest, more than 4 rib fractures without flail chest, multiple anterior rib fractures with sternal fractures, bilateral fractures, severely displaced sternal fractures),pulmonary contusion.
Who cannot join
- Patients were excluded if they had a history of tuberculosis, heart failure,respiratory failure,severe brain injury(GSC score < 15),loss of consciousness, spinal fracture complicated with paraplegia,abdominal trauma requiring surgical intervention,shock.
About this study
Pulmonary contusion caused by severe thoracic trauma is a complex disease. Some patients may be secondary to severe complications such as pulmonary infection or even acute respiratory distress syndrome. At present, there have been no reports on related studies based on Chinese population. In this study, 800 patients with pulmonary contusion will be retrospectively investigated to determine the risk factors and independent risk factors of their poor prognosis, and to construct a prognosis prediction model and scoring criteria.
- Keywords
- pulmonary contusion, severe chest trauma, prediction model
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Group of poor prognosis | In this group,the patients had suffered from systemic infection,pulmonary complications or died. | |
| Group of good prognosis | In this group,the patients were safely discharged without complications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To build a prognostic prediction model and standard scoring system for pulmonary contusion caused by severe chest trauma
In this study, 800 patients with pulmonary contusion will be retrospectively investigated to determine the risk factors and independent risk factors of their poor prognosis, and to construct a prognosis prediction model and scoring criteria.
Measured: 2020.1-2020.6,enter data by protocol, statistical analysis,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Jan 2014
- Primary completion30 Jun 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Contusion , Chest Trauma , Prediction ModelStudies 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
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Wang, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518904
- Sponsor's protocol ID
- ynhg201919
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- 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 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Prognosis Prediction Model and Scoring Criteria of Pulmonary Contusion Caused by Severe Thoracic Trauma
- ClinicalTrials.gov ID
- NCT04518904
- Acronym / sponsor ID
- ynhg201919
- Keywords
- pulmonary contusion, severe chest trauma, prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Aug 2020 (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.
Pulmonary contusion caused by severe thoracic trauma is a complex disease. Some patients may be secondary to severe complications such as pulmonary infection or even acute respiratory distress syndrome. At present, there have been no reports on related studies based on Chinese population. In this study, 800 patients with pulmonary contusion will be retrospectively investigated to determine the risk factors and independent risk factors of their poor prognosis, and to construct a prognosis prediction model and scoring criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of poor prognosis | – | –In this group,the patients had suffered from systemic infection,pulmonary complications or died. |
| Group of good prognosis | – | –In this group,the patients were safely discharged without complications. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 800 cases of patients were hospitalized from 2014 to 2019.All patients were Chinese.
Key inclusion criteria (1 listed)
- Chinese patients aged 18 to 80 years,severe chest trauma (flail chest, more than 4 rib fractures without flail chest, multiple anterior rib fractures with sternal fractures, bilateral fractures, severely displaced sternal fractures),pulmonary contusion.
Key exclusion criteria (1 listed)
- Patients were excluded if they had a history of tuberculosis, heart failure,respiratory failure,severe brain injury(GSC score < 15),loss of consciousness, spinal fracture complicated with paraplegia,abdominal trauma requiring surgical intervention,shock.
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 |
|---|---|---|
| Other | Group of good prognosis, Group of poor prognosis |
Primary outcome
To build a prognostic prediction model and standard scoring system for pulmonary contusion caused by severe chest trauma
Time frame: 2020.1-2020.6,enter data by protocol, statistical analysis,
In this study, 800 patients with pulmonary contusion will be retrospectively investigated to determine the risk factors and independent risk factors of their poor prognosis, and to construct a prognosis prediction model and scoring criteria.
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 19 Aug 2020.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Contusion , Chest Trauma , Prediction Model, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
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 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
To build a prognostic prediction model and standard scoring system for pulmonary contusion caused by severe chest trauma (time frame: 2020.1-2020.6,enter data by protocol, statistical analysis,). 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 19 Aug 2020.