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

Sponsor
Changhai Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05718830
Collaborator
(none)
21
Enrollment
1
Location
12
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    21 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jan 1, 2021
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    patients with traumatic lung injury (TLI)
    patients with inhalation injury (ILI)
    health controls(HCs)

    Outcome Measures

    Primary Outcome Measures

    1. Computerized tomography, CT [1day]

      according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image

    2. Computerized tomography, CT [3 day]

      according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image

    3. Computerized tomography, CT [through study completion, an average of 2 weeks]

      according to the proportion of rib fracture, pneumothorax, hemothorax,lung contusion in the image

    4. Partial pressure of carbon dioxide in arterial blood, PaCO2 [1day]

    5. Partial pressure of carbon dioxide in arterial blood, PaCO2 [3 day]

    6. Partial pressure of carbon dioxide in arterial blood, PaCO2 [through study completion, an average of 2 weeks]

    7. Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2 [1 day]

    8. Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2 [3 day]

    9. Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2 [through study completion, an average of 2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Burn Surgery, the First Affiliated Hospital of Naval Medical University ShangHai Shanghai China 200433

    Sponsors and Collaborators

    • Changhai Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Changhai Hospital
    ClinicalTrials.gov Identifier:
    NCT05718830
    Other Study ID Numbers:
    • ChiCTR2200056981
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Respiratory Aspiration
    Lung Injury
    Respiratory Distress Syndrome
    Wounds and Injuries

    Study Results

    No Results Posted as of Feb 8, 2023