Ultrasonography in Norwegian Emergency Department Patients With Suspected Covid-19 Infection

COVID-19 Clinical Trial

— COVIDUS-NOR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04422691
• Other study ID #: REK129805
• Status: Terminated
• Start date: July 1, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: June 2021
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infection
• Pneumonia
• Pneumonia, Viral
• Pulmonary Infection

Intervention

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.

Locations

Country	Name	City	State
Norway	Haukeland universitetssykehus	Bergen
Norway	Nordland Hospital	Bodø
Norway	Drammen sykehus	Drammen
Norway	Sørlandet sykehus, Kristiansand	Kristiansand
Norway	Akershus University Hospital	Oslo
Norway	Ullevål University Hospital	Oslo
Norway	Sykehuset Telemark HF	Skien
Norway	Stavanger Universitetssjukehus	Stavanger
Norway	St Olavs Hospital	Trondheim

Sponsors (9)

Lead Sponsor	Collaborator
St. Olavs Hospital	Drammen sykehus, Haukeland University Hospital, Helse Stavanger HF, Nordlandssykehuset HF, Sorlandet Hospital HF, Sykehuset Telemark, Ullevaal University Hospital, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical correlation	Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.	Within 3 days
Primary	Mortality	30-day mortality	up to 30 days
Primary	Level-of-care	In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.	up to 7 days
Secondary	In-hospital length of stay	in days	Up to 30 days
Secondary	Oxygen usage in the emergency department		Within 24 hours
Secondary	Emergency department length of stay	in hours	Within 24 hours
Secondary	Antibiotics usage		Within 24 hours