Selecting Specific Bio-markers and Researching Mechanisms of Immune Regulation From Inhalation Injury and Traumatic Lung Injury Based on Single Cell Sequencing Technology

Inhalation Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05718830
• Other study ID #: ChiCTR2200056981
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inhalation Injury
• Lung Injury
• Respiratory Aspiration
• Respiratory Distress Syndrome
• Wounds and Injuries

Locations

Country	Name	City	State
China	Department of Burn Surgery, the First Affiliated Hospital of Naval Medical University	ShangHai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computerized tomography, CT	according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image	1day
Primary	Computerized tomography, CT	according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image	3 day
Primary	Computerized tomography, CT	according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image	through study completion, an average of 2 weeks
Primary	Partial pressure of carbon dioxide in arterial blood, PaCO2		1day
Primary	Partial pressure of carbon dioxide in arterial blood, PaCO2		3 day
Primary	Partial pressure of carbon dioxide in arterial blood, PaCO2		through study completion, an average of 2 weeks
Primary	Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2		1 day
Primary	Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2		3 day
Primary	Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2		through study completion, an average of 2 weeks