Predictivity of Hemogasanalysis and Lung UltraSound in Determining COVID-19 Severity

Covid19 Clinical Trial

— COVID-PEGALUS  

Official title:

Predictivity of hEmoGasAnalysis Associated to Bedside Lung UltraSound in Determining COVID-19 Severity in the Emergency Departement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689672
• Other study ID #: COVID-PEGALUS
• Status: Recruiting
• Start date: December 16, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: December 2020
• Source: IRCCS San Raffaele
• Contact: Paola AM Maffi, MD, PhD
• Phone: +390226432575
• Email: maffi.paola[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This retrospective-prospective longitudinal observational study was designed to evaluate the role of bedside lung ultrasound per se and in association with hemogasanalysis parameters in predicting the severity of COVID-19 patients in the Emergency Departement (ED).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: May 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• SARS - CoV 2 infection confirmed by positive RT-PCR on nasopharyngeal swab

Exclusion Criteria:

• impossibility to perform lung ultrasound due to technical limitations.

Related Conditions & MeSH terms

• Covid19

Intervention

Diagnostic Test:
• Lung ultrasound
Bedside lung ultrasound

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. eColle — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' short-term outcome	Patients' outcome at time of discharge from the Emergency Departement, expressed in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death).	Up to 7 days
Secondary	Patients' long-term outcome	Patients' outcome 30 days after access to the Emergency Departement, expressed in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death).	30 days after access to the Emergency Departement
Secondary	Intensity of care	Required intensity of care during the observational period in the Emergency Departement (eg need for non-invasive ventilation, oro-tracheal intubation).	Up to 7 days