Predictivity of Hemogasanalysis and Lung UltraSound in Determining COVID-19 Severity
NCT ID: NCT04689672
Last Updated: 2020-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
600 participants
OBSERVATIONAL
2020-12-16
2021-05-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Retrospective data regarding patients who presented at the ED of IRCCS San Raffaele Hospital from 10/11/2020, together with those acquired by the observation of patients who will access to the ED until 10/05/2021 will be collected, configuring a total enrollment period of 6 months.
Clinical informations about patients' medical history will be recorded, with particular focus on the type and date of onset of the symptoms. The diagnostic and therapeutic strategy will be chosen according to the current standard of care. Results of bedside lung ultrasound, together with vital parameters, blood gas analysis, laboratory and other findings will be recorded.
The primary outcome will be defined as patients' outcome at time of discharge from the ED, in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death). Secondary outcomes will be patients' prognosis 30 days after access to ED and the required intensity of care (eg need for non-invasive ventilation, oro-tracheal intubation).The follow-up 30 days after access to the ED will be evaluated by telephone survey or by consulting medical records.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lung ultrasound
Bedside lung ultrasound
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS San Raffaele
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paola Maffi
Associate Professor in Internal Medicine; Head of School of Emergency Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Paola AM Maffi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IRCCS San Raffaele
Milan, MI, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Paola AM Maffi, MD, PhD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Khalili N, Haseli S, Iranpour P. Lung Ultrasound in COVID-19 Pneumonia: Prospects and Limitations. Acad Radiol. 2020 Jul;27(7):1044-1045. doi: 10.1016/j.acra.2020.04.032. Epub 2020 May 3. No abstract available.
Smith MJ, Hayward SA, Innes SM, Miller ASC. Point-of-care lung ultrasound in patients with COVID-19 - a narrative review. Anaesthesia. 2020 Aug;75(8):1096-1104. doi: 10.1111/anae.15082. Epub 2020 Apr 28.
Lu X, Zhang M, Qian A, Tang L, Xu S. Lung ultrasound score in establishing the timing of intubation in COVID-19 interstitial pneumonia: A preliminary retrospective observational study. PLoS One. 2020 Sep 3;15(9):e0238679. doi: 10.1371/journal.pone.0238679. eCollection 2020.
Manivel V, Lesnewski A, Shamim S, Carbonatto G, Govindan T. CLUE: COVID-19 lung ultrasound in emergency department. Emerg Med Australas. 2020 Aug;32(4):694-696. doi: 10.1111/1742-6723.13546. Epub 2020 Jun 16.
Dargent A, Chatelain E, Kreitmann L, Quenot JP, Cour M, Argaud L; COVID-LUS study group. Lung ultrasound score to monitor COVID-19 pneumonia progression in patients with ARDS. PLoS One. 2020 Jul 21;15(7):e0236312. doi: 10.1371/journal.pone.0236312. eCollection 2020.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COVID-PEGALUS
Identifier Type: -
Identifier Source: org_study_id