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NCT04503057
Exhaled Breath Particles as a Clinical Indicator for Lung Injury and Acute Respiratory Distress Syndrome (ARDS)
trial in Covid19 in 300 participants. Status unknown.
1 May 2024
Quick facts
| Lead sponsor | Lund University Hospital |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 May 2020 |
| Primary completion | 1 May 2024 |
| Estimated completion | 1 May 2025 |
| Sites | 1 location across Sweden |
Conditions studied
- Covid19 — all drugs for Covid19 →
- ARDS, Human — all drugs for ARDS, Human →
- ALI — all drugs for ALI →
Sponsor
Lund University Hospital
Who can join
Adults 16 to 90, any sex, with Covid19 or ARDS, Human. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Proteomic characteristics and diagnostic potential of exhaled breath particles in patients with COVID-19.
Hirdman G, Bodén E, Kjellström S, Fraenkel CJ, et al · · 2023 · cited 7× · PMID 36967377 · DOI 10.1186/s12014-023-09403-2 -
Particle flow rate from the airways as fingerprint diagnostics in mechanical ventilation in the intensive care unit: a randomised controlled study.
Hallgren F, Stenlo M, Niroomand A, Broberg E, et al · · 2021 · cited 7× · PMID 34322553 · DOI 10.1183/23120541.00961-2020
Verify or expand the search:
- PubMed search for NCT04503057
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04503057 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lund University Hospital
- Last refreshed: 12 April 2022
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