Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-01 @ 2:54 PM
Study NCT ID:
NCT04503057
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2020-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exhaled Breath Particles as a Clinical Indicator for Lung Injury and Acute Respiratory Distress Syndrome (ARDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples, broncho alveolar lavage sample, exhaled breath particles'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of COVID-19 through PCR testing of EBPs', 'timeFrame': '12-36 months', 'description': '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.'}, {'measure': 'Protein concentration in EBP', 'timeFrame': '12-36 months', 'description': 'Proteins will be measured in the samples of EBPs collected on the membrane for the purpose of identifying protein biomarkers of disease.'}, {'measure': 'Particle flow rate (particles per minute) in exhaled air', 'timeFrame': '12-36 months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exhaled Breath Particles', 'Particles in Exhaled Air (PExA)', 'COVID-19', 'ARDS', 'ALI'], 'conditions': ['Covid19', 'ARDS, Human', 'ALI']}, 'referencesModule': {'references': [{'pmid': '32055633', 'type': 'BACKGROUND', 'citation': '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': '31994907', 'type': 'BACKGROUND', 'citation': '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': '31615381', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nThe 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))\n\nMeasurements are also planned for patients who are on mechanical ventilation on extracorporeal membrane oxygenation (ECMO) support as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pulmonary infection, ALI or ARDS. Patients on mechanical ventilation. Normal breathing patients. Patients on ECMO support.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of ALI\n* Clinical diagnosis of ARDS\n* COVID-19 infection as measured by a positive PCR test\n\nExclusion Criteria:\n\n* Dementia\n* Severe neurological disease\n* Drug abuse'}, 'identificationModule': {'nctId': 'NCT04503057', 'briefTitle': 'Exhaled Breath Particles as a Clinical Indicator for Lung Injury and Acute Respiratory Distress Syndrome (ARDS)', 'organization': {'class': 'OTHER', 'fullName': 'Lund University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PEx ARDS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 positive', 'description': 'COVID-19-positive patients with pulmonary infection, ALI or ARDS'}, {'label': 'COVID-19 negative', 'description': 'COVID-19-negative patients with pulmonary infection, ALI or ARDS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22460', 'city': 'Lund', 'state': 'Skåne County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Sandra Lindstedt Ingemansson, MD, PhD', 'role': 'CONTACT', 'email': 'sandra.lindstedt_ingemansson@med.lu.se', 'phone': '0737220580'}, {'name': 'Leif Pierre, PhD', 'role': 'CONTACT', 'email': 'leif.pierre@skane.se', 'phone': '+46703096605'}], 'facility': 'Region Skåne', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'centralContacts': [{'name': 'Sandra Lindstedt Ingemansson, MD, PhD', 'role': 'CONTACT', 'email': 'sandra.lindstedt_ingemansson@med.lu.se', 'phone': '+46737220580'}, {'name': 'Leif Pierre, PhD', 'role': 'CONTACT', 'email': 'leif.pierre@skane.se', 'phone': '+467073096605'}], 'overallOfficials': [{'name': 'Sandra Lindstedt Ingemansson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Skåne, Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}