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
|Condition or disease|
|Covid19 ARDS, Human ALI|
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 Pre-clinical studies have shown that EBP can measure the extent of lung injury over time (onset of ARDS and recovery (unpublished data))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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|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|
COVID-19-positive patients with pulmonary infection, ALI or ARDS
COVID-19-negative patients with pulmonary infection, ALI or ARDS
- 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.
Biospecimen Retention: Samples With DNA
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
|Contact: Sandra Lindstedt Ingemansson, MD, PhDemail@example.com|
|Contact: Leif Pierre, PhDfirstname.lastname@example.org|
|Principal Investigator:||Sandra Lindstedt Ingemansson, MD, PhD||Region Skåne, Lund University|