Traumatic Lung InjuryNCT05718830
Selecting Specific Bio-markers and Researching Mechanisms of Immune Regulation From Inhalation Injury and Traumatic Lung Injury Based on Single Cell Sequencing Technology
An observational study of Traumatic Lung Injury and Inhalation Injury, run by Changhai Hospital at 1 site in China.
Trial summary
The goal of this observational study is to profile the circulating immunological traits of patients with traumatic lung injury (TLI) and inhalation injury (ILI),providing a new direction for the depth research of the pathogenesis, and providing new immune-related targets for diagnosis of the severity of lung injury… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Lung Injury, Inhalation Injury
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3 patients with TLI and 3 patients with ILI age from 18 to 90 years old, admission within 24h after injury and diagnosed as traumatic lung injury by 2 surgeons on account of injury history and chest CT images. As well as peripheral blood from 3 health controls(HCs) who have no smoking history.
Who may be able to join
- Lung injury caused by burn trauma is confirmed, and the patient is hospitalized within 24 hours after burn or trauma (the clinician can make a definite diagnosis of lung injury based on the comprehensive judgment of the patient's etiology, history, clinical manifestations, blood gas analysis, laboratory tests and imaging);
- Patients with inhalation injury caused by head, face and neck burns or inhalation injury combined with multiple body burns < 30%;
- Patients with simple inhalation injury;
- The normal control group should have no smoking history and be normal population;
- According to the provisions of Good Clinical Practice(GCP), the informed consent has been obtained and the informed consent has been signed to volunteer for the test.
Who cannot join
- Basic pulmonary diseases like chronic obstructive pulmonary disease (COPD), asthma and et al;
- Severe organ dysfunction;
- Autoimmune diseases;
- Tumor;
- Severe infection;
- Pregnant or nursing women;
- Fatal or life-threatening events caused by trauma;
- Any history which may interfere the results or increase the risk of patients judged by researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Burn Surgery, the First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200433
About this study
The goal of this observational study is to profile the circulating immunological traits of patients with traumatic lung injury (TLI) and inhalation injury (ILI),providing a new direction for the depth research of the pathogenesis, and providing new immune-related targets for diagnosis of the severity of lung injury and treatment.
The investigators performed scRNA-seq of neutrophil and peripheral blood mononuclear cells (PBMCs) from 10 ml fresh circulating blood from 3 patients with TLI and 3 patients with ILI at longitudinal timepoints,as well as peripheral blood from 3 health controls(HCs).
Read the detailed description
The investigators performed single-cell transcriptomic sequencing (BD Rhapsody) on neutrophil and PBMCs extracted from the fresh circulating blood from 3 patients with TLI and 3 patients with ILI at longitudinal timepoints,as well as peripheral blood from 3 health controls(HCs). Three time points are picked by clinical conditions of patients with TLI or ILI: day 1 post hospital admission, day 3 post hospital and the day before discharged which matched to acute stage,progressive stage and convalescence.
- Conditions
- Traumatic Lung Injury, Inhalation Injury
- Medical subject headings
- Lung Injury
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 |
|---|---|---|
| patients with traumatic lung injury (TLI) | Not described | |
| patients with inhalation injury (ILI) | Not described | |
| health controls(HCs) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized tomography, CT
according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image
Measured: 1day
Computerized tomography, CT
according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image
Measured: 3 day
Computerized tomography, CT
according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image
Measured: through study completion, an average of 2 weeks
Partial pressure of carbon dioxide in arterial blood, PaCO2
Measured: 1day
Partial pressure of carbon dioxide in arterial blood, PaCO2
Measured: 3 day
Partial pressure of carbon dioxide in arterial blood, PaCO2
Measured: through study completion, an average of 2 weeks
Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2
Measured: 1 day
Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2
Measured: 3 day
Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2
Measured: through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Lung InjuryStudies of the same condition, open and under way.
- More trials run by Changhai 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718830
- Sponsor's protocol ID
- ChiCTR2200056981
- Status last verified
- Dec 2022
- First submitted
- 25 Dec 2022
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selecting Specific Bio-markers and Researching Mechanisms of Immune Regulation From Inhalation Injury and Traumatic Lung Injury Based on Single Cell Sequencing Technology
- ClinicalTrials.gov ID
- NCT05718830
- Acronym / sponsor ID
- ChiCTR2200056981
- Conditions
- Traumatic Lung Injury, Inhalation Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Feb 2023 (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 profile the circulating immunological traits of patients with traumatic lung injury (TLI) and inhalation injury (ILI),providing a new direction for the depth research of the pathogenesis, and providing new immune-related targets for diagnosis of the severity of lung injury and treatment.
The investigators performed scRNA-seq of neutrophil and peripheral blood mononuclear cells (PBMCs) from 10 ml fresh circulating blood from 3 patients with TLI and 3 patients with ILI at longitudinal timepoints,as well as peripheral blood from 3 health controls(HCs).
Detailed description
The investigators performed single-cell transcriptomic sequencing (BD Rhapsody) on neutrophil and PBMCs extracted from the fresh circulating blood from 3 patients with TLI and 3 patients with ILI at longitudinal timepoints,as well as peripheral blood from 3 health controls(HCs). Three time points are picked by clinical conditions of patients with TLI or ILI: day 1 post hospital admission, day 3 post hospital and the day before discharged which matched to acute stage,progressive stage and convalescence.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with traumatic lung injury (TLI) | – | – |
| patients with inhalation injury (ILI) | – | – |
| health controls(HCs) | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3 patients with TLI and 3 patients with ILI age from 18 to 90 years old, admission within 24h after injury and diagnosed as traumatic lung injury by 2 surgeons on account of injury history and chest CT images. As well as peripheral blood from 3 health controls(HCs) who have no smoking history.
Key inclusion criteria (5 listed)
- Lung injury caused by burn trauma is confirmed, and the patient is hospitalized within 24 hours after burn or trauma (the clinician can make a definite diagnosis of lung injury based on the comprehensive judgment of the patient's etiology, history, clinical manifestations, blood gas analysis, laboratory tests and imaging);
- Patients with inhalation injury caused by head, face and neck burns or inhalation injury combined with multiple body burns < 30%;
- Patients with simple inhalation injury;
- The normal control group should have no smoking history and be normal population;
- According to the provisions of Good Clinical Practice(GCP), the informed consent has been obtained and the informed consent has been signed to volunteer for the test.
Key exclusion criteria (8 listed)
- Basic pulmonary diseases like chronic obstructive pulmonary disease (COPD), asthma and et al;
- Severe organ dysfunction;
- Autoimmune diseases;
- Tumor;
- Severe infection;
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
Computerized tomography, CT
Time frame: 1day
according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image
Computerized tomography, CT
Time frame: 3 day
according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image
Computerized tomography, CT
Time frame: through study completion, an average of 2 weeks
according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image
Partial pressure of carbon dioxide in arterial blood, PaCO2
Time frame: 1day
Partial pressure of carbon dioxide in arterial blood, PaCO2
Time frame: 3 day
Partial pressure of carbon dioxide in arterial blood, PaCO2
Time frame: through study completion, an average of 2 weeks
Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2
Time frame: 1 day
Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2
Time frame: 3 day
Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2
Time frame: through study completion, an average of 2 weeks
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 8 Feb 2023.
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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 Traumatic Lung Injury and Inhalation Injury, run by Changhai 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 5 inclusion and 8 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 8 Feb 2023. 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?
Computerized tomography, CT (time frame: 1day). The study lists 9 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 8 Feb 2023.