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

NCT04503057 | Unknown DMC

• 1 other identifier: PEx ARDS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; ARDS, Human; ALI

Keywords

Exhaled Breath Particles; Particles in Exhaled Air (PExA); COVID-19; ARDS; ALI

Outcome Measures

Primary Outcomes (3)

• Concentration of COVID-19 through PCR testing of EBPs

  Real Time-PCR will be used to detect the presence of COVID-19 on membranes on which EBP have been collected to determine the efficacy of using the collection device for non-invasive detection of infection.

  12-36 months

• Protein concentration in EBP

  Proteins will be measured in the samples of EBPs collected on the membrane for the purpose of identifying protein biomarkers of disease.

  12-36 months

• Particle flow rate (particles per minute) in exhaled air

  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 (similar to ARDS) in lung transplant patients and for ARDS in a large animal model. PFR has been shown to increase before the cytokine storm which is a hallmark of ARDS. Early detection of ALI and ARDS is crucial for increasing a patient's chance of survival as it allows for early treatment, such as preparing for intensive care, prone positioning and protective mechanical ventilation settings. In the present study the investigators aim to use real-time PFR as an early detector for COVID-19-induced ARDS.

  12-36 months

Study Arms (2)

COVID-19 positive

COVID-19-positive patients with pulmonary infection, ALI or ARDS

COVID-19 negative

COVID-19-negative patients with pulmonary infection, ALI or ARDS

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pulmonary infection, ALI or ARDS. Patients on mechanical ventilation. Normal breathing patients. Patients on ECMO support.

You may qualify if:

• Clinical diagnosis of ALI
• Clinical diagnosis of ARDS
• COVID-19 infection as measured by a positive PCR test

You may not qualify if:

• Dementia
• Severe neurological disease
• Drug abuse

Sponsors & Collaborators

• Lund University Hospital: lead

Study Sites (1)

Region Skåne

Lund, Skåne County, 22460, Sweden

RECRUITING

Related Publications (3)

• Broberg E, Andreasson J, Fakhro M, Olin AC, Wagner D, Hyllen S, Lindstedt S. Mechanically ventilated patients exhibit decreased particle flow in exhaled breath as compared to normal breathing patients. ERJ Open Res. 2020 Feb 10;6(1):00198-2019. doi: 10.1183/23120541.00198-2019. eCollection 2020 Jan.

  PMID: 32055633 BACKGROUND

• Stenlo M, Hyllen S, Silva IAN, Bolukbas DA, Pierre L, Hallgren O, Wagner DE, Lindstedt S. Increased particle flow rate from airways precedes clinical signs of ARDS in a porcine model of LPS-induced acute lung injury. Am J Physiol Lung Cell Mol Physiol. 2020 Mar 1;318(3):L510-L517. doi: 10.1152/ajplung.00524.2019. Epub 2020 Jan 29.

  PMID: 31994907 BACKGROUND

• Broberg E, Hyllen S, Algotsson L, Wagner DE, Lindstedt S. Particle Flow Profiles From the Airways Measured by PExA Differ in Lung Transplant Recipients Who Develop Primary Graft Dysfunction. Exp Clin Transplant. 2019 Dec;17(6):803-812. doi: 10.6002/ect.2019.0187. Epub 2019 Oct 11.

  PMID: 31615381 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, broncho alveolar lavage sample, exhaled breath particles

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Sandra Lindstedt Ingemansson, MD, PhD

  Region Skåne, Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Lindstedt Ingemansson, MD, PhD

CONTACT

+46737220580; sandra.lindstedt_ingemansson@med.lu.se

Leif Pierre, PhD

CONTACT

+467073096605; leif.pierre@skane.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: April 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)