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
|Condition or disease|
|Covid19 ARDS, Human ALI|
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 Preclinical studies have shown that EBP can measure the extent of lung injury over time (onset of ARDS and recovery (unpublished data)) Method: EBP will be measured on 100 patients in mechanical ventilation at the intensive care on daily bases to follow the EBP pattern over time.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.
|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 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|
Positive COVID-19 patients with pulmonary infection, ALI or ARDS
Negative COVID-19 patients with pulmonary infection, ALI or ARDS
- COVID-19 RT-PCR detection in EBP [ Time Frame: 12-36 months ]Detect COVID-19 in EBP using RT-PCR
- Detection of proteins biomarkers in EBP [ Time Frame: 12-36 months ]Detection of proteins biomarkers in EBP
- 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
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|