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

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

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: Lung ultrasound

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Paola AM Maffi, MD, PhD; Phone Number: +390226432575; Email: maffi.paola@hsr.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • Recruiting
      • IRCCS San Raffaele
      • Contact: Paola AM Maffi, MD, PhD; Phone Number: +390226432575; Email: paola.maffi@hsr.it
      • Sub-Investigator: Stefano Tentori, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to IRCCS San Raffaele Hospital Emergency Departement with SARS CoV-2 documented infection from 10/11/2020 to 10/05/2021.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Paola AM Maffi, MD, PhD, IRCCS San Raffaele Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Anticipated): May 10, 2021
• Study Completion (Anticipated): May 10, 2021

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COVID-PEGALUS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No