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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 : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Lund University Hospital

Brief 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.

Condition or disease
Covid19 ARDS, Human ALI

Detailed 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.

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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 Syndrom (ARDS) in COVID-19 Positive and Negative Patients
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2024


Group/Cohort
COVID-19 positive
Positive COVID-19 patients with pulmonary infection, ALI or ARDS
COVID-19 negative
Negative COVID-19 patients with pulmonary infection, ALI or ARDS



Primary Outcome Measures :
  1. COVID-19 RT-PCR detection in EBP [ Time Frame: 12-36 months ]
    Detect COVID-19 in EBP using RT-PCR

  2. Detection of proteins biomarkers in EBP [ Time Frame: 12-36 months ]
    Detection of proteins biomarkers in EBP

  3. Particle flow rate as an early indicator for lung injury [ Time Frame: 12-36 months ]
    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.


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


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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with pulmonary infection, ALI or ARDS. Patients in mechanical ventilation. Normal breathing patients. Patients on ECMO support.
Criteria

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


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
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: August 6, 2020
Last Verified: May 2020
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
PExA
COVID-19
ARDS
ALI
Additional relevant MeSH terms:
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Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders