Official Title
Exhaled Breath Particles as a Clinical Indicator for Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) in Coronavirus (Covid-19) Positive and Negative Patients
Brief Summary

Acute Respiratory Distress Syndrome (ARDS) reflects the hallmark of the critical course of coronavirus (COVID19). The investigators have recently shown that Exhaled Breath Particles (EBP) measured as particle flow rate (PFR) from the airways could be used as a noninvasive real-time early detection method for primary graft dysfunction (which bears a pathophysiological resemblance to ARDS) in lung transplant patients. The investigators have also previously demonstrated the utility of PFR in early detection and monitoring of ARDS in a large animal model. PFR has been shown to be elevated prior to the cytokine storm which classically occurs in ARDS. Early detection of ALI and ARDS is intimately linked to a patient's chance of survival as early treatment consisting of the preparation for intensive care, prone positioning and protective mechanical ventilation can be implemented early in the process. In the present study the investigators aim to use real-time PFR as an early detector for COVID19-induced ARDS. The investigators will also collect EBPs onto a membrane for subsequent molecular analysis. Previous studies have shown that most of those proteins found in bronchoalveolar lavage (BAL) can also be detected in EBPs deposited on membranes. The investigators therefore also aim to be able to diagnose COVID19 by analyzing EBPs using Polymerase Chain Reaction (PCR) with the same specificity as PCR from BAL, with the added benefit of being able to identify protein biomarkers for early detection of ARDS.

Detailed Description

EBP will be measured on 100 patients who are coronavirus (COVID-19) positive as indicated by
PCR tests. Measurement will be done on daily basis from the time the patient is admitted to
the hospital as an inpatient until either discharge or transition to ICU care. The initiation
of mechanical ventilation in ICU patients will facilitate the tracking of EBP patterns over
the course of disease in each patient. EBP measurements will also be done on 100 patients
without COVID19 infection who have normal lung function as a control cohort.

The study will involve measurements on patients who have been placed on mechanical
ventilation in the ICU. The purpose of utilizing PFR will be to reduce the need for invasive
diagnostic tests such as bronchoscopy and for hospital transportation associated with tests
such as CT scans. This will ultimately serve to not only decrease the risk of infecting other
patients and staff in the hospital environment, but also to facilitate careful monitoring of
these critical patients by measuring the extent of lung injury over time. In addition to PFR,
EBP will be collected and measured on a daily basis to track the EBP patterns on patients in
mechanical ventilation. Pre-clinical studies have shown that EBP can measure the extent of
lung injury over time (onset of ARDS and recovery (unpublished data))

Measurements are also planned for patients who are on mechanical ventilation on
extracorporeal membrane oxygenation (ECMO) support as well.

Recruiting
COVID19
ARDS, Human
ALI
Eligibility Criteria

Inclusion Criteria:

- Clinical diagnosis of ALI

- Clinical diagnosis of ARDS

- COVID-19 infection as measured by a positive PCR test

Exclusion Criteria:

- Dementia

- Severe neurological disease

- Drug abuse

Eligibility Gender
All
Eligibility Age
Minimum: 16 Years ~ Maximum: 90 Years
Countries
Sweden
Locations

Region Skåne
Lund, Skåne Län, Sweden

Investigator: Sandra Lindstedt Ingemansson, MD, PhD
Contact: 0737220580
sandra.lindstedt_ingemansson@med.lu.se

Contacts

Sandra Lindstedt Ingemansson, MD, PhD
+46737220580
sandra.lindstedt_ingemansson@med.lu.se

Leif Pierre, PhD
+467073096605
leif.pierre@skane.se

Sandra Lindstedt Ingemansson, MD, PhD, Principal Investigator
Region Skåne, Lund University

Lund University Hospital
NCT Number
Keywords
Exhaled Breath Particles
Particles in Exhaled Air (PExA)
Covid-19
ARDS
ALI
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Injury