Clinical trial NCT05718830: Selecting Specific Bio-markers and Researching Mechanisms of Immune Regulation From Inhalation Injury and Traumatic Lung Injury Based on Single Cell Sequencing Technology
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Lung Injury
Inhalation Injury
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. 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);
2. Patients with inhalation injury caused by head, face and neck burns or inhalation injury combined with multiple body burns \< 30%;
3. Patients with simple inhalation injury;
4. The normal control group should have no smoking history and be normal population;
5. 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.

Exclusion Criteria:

1. Basic pulmonary diseases like chronic obstructive pulmonary disease (COPD), asthma and et al;
2. Severe organ dysfunction;
3. Autoimmune diseases;
4. Tumor;
5. Severe infection;
6. Pregnant or nursing women;
7. Fatal or life-threatening events caused by trauma;
8. Any history which may interfere the results or increase the risk of patients judged by researchers.

Primary outcomes:
measure: Computerized tomography, CT
timeFrame: 1day
measure: Computerized tomography, CT
timeFrame: 3 day
measure: Computerized tomography, CT
timeFrame: through study completion, an average of 2 weeks
measure: Partial pressure of carbon dioxide in arterial blood, PaCO2
timeFrame: 1day
measure: Partial pressure of carbon dioxide in arterial blood, PaCO2
timeFrame: 3 day
measure: Partial pressure of carbon dioxide in arterial blood, PaCO2
timeFrame: through study completion, an average of 2 weeks
measure: Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2
timeFrame: 1 day
measure: Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2
timeFrame: 3 day
measure: Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Department of Burn Surgery, the First Affiliated Hospital of Naval Medical University
state: Shanghai
Study officials:
References: