NCT05718830

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

December 1, 2022

Enrollment Period

12 months

First QC Date

December 25, 2022

Last Update Submit

January 30, 2023

Conditions

Traumatic Lung InjuryInhalation Injury

Outcome Measures

Primary Outcomes (9)

  • Computerized tomography, CT

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

    1day

  • Computerized tomography, CT

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

    3 day

  • 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

  • Partial pressure of carbon dioxide in arterial blood, PaCO2

    1day

  • Partial pressure of carbon dioxide in arterial blood, PaCO2

    3 day

  • Partial pressure of carbon dioxide in arterial blood, PaCO2

    through study completion, an average of 2 weeks

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

    1 day

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

    3 day

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

    through study completion, an average of 2 weeks

Study Arms (3)

patients with traumatic lung injury (TLI)

patients with inhalation injury (ILI)

health controls(HCs)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2022

First Posted

February 8, 2023

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 8, 2023

Record last verified: 2022-12

Locations

CN(1)