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

NCT04689672 | Unknown

• 1 other identifier: COVID-PEGALUS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patients' long-term outcome

  30 days after access to the Emergency Departement

• Intensity of care

  Up to 7 days

Interventions

Lung ultrasound DIAGNOSTIC_TEST

Bedside lung ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• impossibility to perform lung ultrasound due to technical limitations.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, MI, 20132, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 32444253 RESULT

• 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.

  PMID: 32275766 RESULT

• 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.

  PMID: 32881950 RESULT

• 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.

  PMID: 32386264 RESULT

• 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.

  PMID: 32692769 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Paola AM Maffi, MD, PhD

  IRCCS San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola AM Maffi, MD, PhD

CONTACT

+390226432575; maffi.paola@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Internal Medicine; Head of School of Emergency Medicine

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 30, 2020
• Study Start: December 16, 2020
• Primary Completion: May 10, 2021
• Study Completion: May 10, 2021
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

IT (1)