Ultrasonography in Norwegian Emergency Department Patients With Suspected Covid-19 Infection (COVIDUS-NOR)

Bruk av Ultralyd i Evaluering av Pasienter Med Mistenkt COVID-19 Infeksjon i Norge

In light of the ongoing COVID-19 epidemic in Norway, it is paramount to develop and utilize clinical tools for assessing and risk stratifying patients with suspected coronary infection in the emergency departments. Diagnostic use of ultrasound in viral pneumonias, including COVID-19 has proved to be very useful. The use of ultrasound will assist in quick detection of lung pathology compatible with increasing severity of the COVID-19 disease. At the same time, the use of ultrasound diagnostics in the emergency department could improve logistics and reduce potential exposure of the corona virus to other health personnel.

The purpose of the study is to assess whether ultrasound findings correlates with physical examination, labs, and other imaging diagnostics in patients with suspected or diagnosed COVID-19 disease, as well as assessing whether ultrasound diagnostics can assist in risk stratification. The project is conducted as a prospective multicenter study where ultrasound diagnostics will be performed on patients with suspected coronary infection in the emergency departments. Data collection takes place as part of the daily clinical evaluation of acute patients in the emergency departments. The project is planned to be completed towards the end of 2025.

Study Overview

• Status: Terminated
• Conditions: COVID-19; Pneumonia, Viral; Pulmonary Infection
• Intervention / Treatment: Diagnostic test: Lung ultrasound

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • Haukeland Universitetssykehus
  • Bodø, Norway
    • Nordland Hospital
  • Drammen, Norway
    • Drammen sykehus
  • Kristiansand, Norway
    • Sørlandet sykehus, Kristiansand
  • Oslo, Norway
    • Akershus University Hospital
  • Oslo, Norway
    • Ullevål University Hospital
  • Skien, Norway
    • Sykehuset Telemark HF
  • Stavanger, Norway
    • Stavanger Universitetssjukehus
  • Trondheim, Norway
    • St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pasients referred to the ED with signs and symptoms suspected of COVID-19 (including cough, dyspnea, fever), patient already diagnosed with COVID-19, and patients with risk of being in contact with corona virus will be eligible for study enrollment.

Description

Inclusion Criteria:

- All emergency department patients with suspected or diagnosed COVID-19.

Exclusion Criteria:

• Negative screening for COVID-19
• recent negative COVID-19 test
• no indication for isolation in the Emergency Department

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Covid-19 suspected; Emergency department patients with suspected or diagnosed COVID-19 disease. All patients will be screened at triage and put into isolation if suspected disease. Ultrasound of the patients lungs will be performed after patient consent and findings will be recorded and categorized (Soldati et al., 2020). The use of ultrasound and registration of data will not affect the regular patient evaluation, treatment or logistics.

Diagnostic test: Lung ultrasound; After verbal consent the enrolled patients' lungs are evaluated with ultrasound while in isolation. The lungs are divided into 3 fields and findings are categorized according to Soldati et al., 2020.; Other Names: Ultrasonography of the lungs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	30-day mortality	up to 30 days
Level-of-care	In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital length of stay	in days	Up to 30 days
Oxygen usage in the emergency department		Within 24 hours
Emergency department length of stay	in hours	Within 24 hours
Antibiotics usage		Within 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical correlation	Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.	Within 3 days

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Ullevaal University Hospital; Helse Stavanger HF; Haukeland University Hospital; Sorlandet Hospital HF; Sykehuset Telemark; University Hospital, Akershus; Nordlandssykehuset HF; Drammen sykehus
• Investigators: Principal Investigator: Lars Petter Bjørnsen, MD, PhD, NTNU/St. Olav's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 6, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Emergency Department; Ultrasonography; Norway; Emergency Physicians
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; COVID-19; Infections; Pneumonia, Viral
• Other Study ID Numbers: REK129805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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