Clinical trial NCT04422691: Ultrasonography in Norwegian Emergency Department Patients With Suspected Covid-19 Infection
Official title: Bruk av Ultralyd i Evaluering av Pasienter Med Mistenkt COVID-19 Infeksjon i Norge
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID-19
Pneumonia, Viral
Pulmonary Infection
Keywords: Ultrasonography
Norway
Emergency Department
Emergency Physicians
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Ullevaal University Hospital
name: Nordlandssykehuset HF
name: Sorlandet Hospital HF
name: Drammen sykehus
name: Sykehuset Telemark
name: Helse Stavanger HF
name: University Hospital, Akershus
First posted: 2020-06-09
Enrollment: 5
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: up to 30 days
measure: Level-of-care
timeFrame: up to 7 days
Secondary outcomes:
measure: In-hospital length of stay
timeFrame: Up to 30 days
measure: Oxygen usage in the emergency department
timeFrame: Within 24 hours
measure: Emergency department length of stay
timeFrame: Within 24 hours
measure: Antibiotics usage
timeFrame: Within 24 hours
Other outcomes:
measure: Clinical correlation
timeFrame: Within 3 days
Locations:
city: Bergen
country: Norway
facility: Haukeland universitetssykehus
city: Bodø
country: Norway
facility: Nordland Hospital
city: Drammen
country: Norway
facility: Drammen sykehus
city: Kristiansand
country: Norway
facility: Sørlandet sykehus, Kristiansand
city: Oslo
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Ullevål University Hospital
city: Skien
country: Norway
facility: Sykehuset Telemark HF
city: Stavanger
country: Norway
facility: Stavanger Universitetssjukehus
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: NTNU/St. Olav's Hospital
name: Lars Petter Bjørnsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: