Covid19NCT04503057
Exhaled Breath Particles as a Clinical Indicator for Lung Injury and Acute Respiratory Distress Syndrome (ARDS)
An observational study of Covid19 and ARDS, Human, run by Lund University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Covid19, ARDS, Human, ALI
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2020to 1 May 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pulmonary infection, ALI or ARDS. Patients on mechanical ventilation. Normal breathing patients. Patients on ECMO support.
Who may be able to join
- Clinical diagnosis of ALI
- Clinical diagnosis of ARDS
- COVID-19 infection as measured by a positive PCR test
Who cannot join
- Dementia
- Severe neurological disease
- Drug abuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Region Skåne
Lund, Skåne County, 22460
Sandra Lindstedt Ingemansson, MD, PhD, 0737220580, sandra.lindstedt_ingemansson@med.lu.se
Leif Pierre, PhD, +46703096605, leif.pierre@skane.se
About this study
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
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.
Read the 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.
- Conditions
- Covid19, ARDS, Human, ALI
- Keywords
- Exhaled Breath Particles, Particles in Exhaled Air (PExA), COVID-19, ARDS, ALI
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 May 2020
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Lindstedt Ingemansson, MD, PhD, Principal investigator, Region Skåne, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503057
- Sponsor's protocol ID
- PEx ARDS
- Status last verified
- Jan 2022
- First submitted
- 3 Aug 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32055633Stenlo 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.
PubMed 31994907Broberg 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.
PubMed 31615381
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04503057
- Acronym / sponsor ID
- PEx ARDS
- Conditions
- Covid19, ARDS, Human, ALI
- Keywords
- Exhaled Breath Particles, Particles in Exhaled Air (PExA), COVID-19, ARDS, ALI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pulmonary infection, ALI or ARDS. Patients on mechanical ventilation. Normal breathing patients. Patients on ECMO support.
Key inclusion criteria (3 listed)
- Clinical diagnosis of ALI
- Clinical diagnosis of ARDS
- COVID-19 infection as measured by a positive PCR test
Key exclusion criteria (3 listed)
- Dementia
- Severe neurological disease
- Drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Background: PubMed 32055633Broberg 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.
- Background: PubMed 31994907Stenlo 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.
- Background: PubMed 31615381Broberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Lindstedt Ingemansson, MD, PhD principal investigator
Region Skåne, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and ARDS, Human, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra Lindstedt Ingemansson, MD, PhD (+46737220580, sandra.lindstedt_ingemansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of COVID-19 through PCR testing of EBPs (time frame: 12-36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04503057, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.