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

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ClinicalTrials.gov Identifier: NCT04503057
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Study Description
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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.

Condition or disease
Covid19 ARDS, Human ALI

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
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
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Concentration of COVID-19 through PCR testing of EBPs [ Time Frame: 12-36 months ]
    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.

  2. Protein concentration in EBP [ Time Frame: 12-36 months ]
    Proteins will be measured in the samples of EBPs collected on the membrane for the purpose of identifying protein biomarkers of disease.

  3. Particle flow rate (particles per minute) in exhaled air [ Time Frame: 12-36 months ]
    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.


Biospecimen Retention:   Samples With DNA
Blood samples, broncho alveolar lavage sample, exhaled breath particles

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with pulmonary infection, ALI or ARDS. Patients on mechanical ventilation. Normal breathing patients. Patients on ECMO support.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503057


Contacts
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Contact: Sandra Lindstedt Ingemansson, MD, PhD +46737220580 sandra.lindstedt_ingemansson@med.lu.se
Contact: Leif Pierre, PhD +467073096605 leif.pierre@skane.se

Locations
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Sweden
Region Skåne Recruiting
Lund, Skåne Län, Sweden, 22460
Contact: Sandra Lindstedt Ingemansson, MD, PhD    0737220580    sandra.lindstedt_ingemansson@med.lu.se   
Contact: Leif Pierre, PhD    +46703096605    leif.pierre@skane.se   
Sponsors and Collaborators
Lund University Hospital
Investigators
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Principal Investigator: Sandra Lindstedt Ingemansson, MD, PhD Region Skåne, Lund University
More Information
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Publications:

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Responsible Party: Lund University Hospital
ClinicalTrials.gov Identifier: NCT04503057    
Other Study ID Numbers: PEx ARDS
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University Hospital:
Exhaled Breath Particles
Particles in Exhaled Air (PExA)
COVID-19
ARDS
ALI
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Injury
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries