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NCT Number: NCT05718830

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

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).

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Key information

Conditions

Traumatic Lung Injury Inhalation Injury Lung Diseases Lung Injury Respiratory Tract Diseases Thoracic Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Burn Surgery, the First Affiliated Hospital of Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Computerized tomography, CT

    Time frame: 1day

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

  2. Computerized tomography, CT

    Time frame: 3 day

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

  3. 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

  4. Partial pressure of carbon dioxide in arterial blood, PaCO2

    Time frame: 1day

  5. Partial pressure of carbon dioxide in arterial blood, PaCO2

    Time frame: 3 day

  6. Partial pressure of carbon dioxide in arterial blood, PaCO2

    Time frame: through study completion, an average of 2 weeks

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

    Time frame: 1 day

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

    Time frame: 3 day

  9. Oxygenation index and Fraction of Inspired Oxygen will be combined to report FiO2/PaO2

    Time frame: through study completion, an average of 2 weeks

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2023
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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