Exhaled Breath Particles as a Clinical Indicator for Lung Injury and Acute Respiratory Distress Syndrome (ARDS)

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    300
  • sponsor
    Lund University Hospital
Updated on 25 January 2021
mechanical ventilation
cytokines
respiratory distress
acute respiratory distress
covid-19
cytokine storm
ventilator-induced lung injury
assisted breathing
lung injury
hypercytokinemia

Summary

Acute Respiratory Distress Syndrome (ARDS) reflects the hallmark of the critical course of COVID19. We have recently shown that Exhaled Breath Particles (EBP) measured as particle flowrate (PFR) from the airways could be used as a noninvasive real time early detection method for primary graft dysfunction (similar to ARDS) in lung transplant patients and for ARDS in a large animal model. PFR increased before the cytokine storm. Early detection of ALI and ARDS is crucial for the patient's chance of survival as early treatment, such as preparing for intensive care, prone position and protective ventilation when the patient is treated in mechanical ventilation, can be implemented early in the process. In the present study we aim to use real time PFR as an early detector for COVID19 induced ARDS. We will also collect EBPs onto a membrane for subsequent molecular analysis. Previous studies have shown that most of those proteins found in broncho alveolar lavage (BAL) are also found in EBP. We therefore also aim to be able to diagnose COVID19 by analyzing EBP using PCR with the same specificity as PCR from BAL, but also to identify protein biomarkers for early detection of ARDS.

Description

EBP will be measured on 100 patients with COVID-19 positive patients. Measurement will be done on daily bases from the time the patient is treated as" in patients" until discharge or to the transition to ICU care and initiation of mechanical ventilation to follow the EBP pattern over time course of the disease. EBP measurements will also be done on 100 patients without COVID19 infection with normal lung function as a control cohort.

Measurements on patients with mechanical ventilation in the ICU. To reduce the need of invasive diagnostics and in hospital transportation for diagnostics with a high risk of infecting other patients and staff in the environment, but also to measure the extent of lung injury over time, EBP will be measured at daily bases to follow the EBP pattern on patients in mechanical ventilation. Preclinical studies have shown that EBP can measure the extent of lung injury over time (onset of ARDS and recovery (unpublished data)) Method: EBP will be measured on 100 patients in mechanical ventilation at the intensive care on daily bases to follow the EBP pattern over time.

Measurements will be done on patients in mechanical ventilation on ECMO (extra corporal membrane oxygenation) support.

Details
Condition Acute Lung Injury, ADULT RESPIRATORY DISTRESS SYNDROME, Acute Respiratory Distress Syndrome (ARDS), COVID19, ALI
Clinical Study IdentifierNCT04503057
SponsorLund University Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with pulmonary infection, ALI or ARDS who are COVID-19 positive in
PCR Patients with pulmonary infection, ALI or ARDS who are COVID-19 negative

Exclusion Criteria

Dementia or other severe neurological disease
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