Ultrasonography in Norwegian Emergency Department Patients With Suspected Covid-19 Infection (COVIDUS-NOR)
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|ClinicalTrials.gov Identifier: NCT04422691|
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : November 25, 2020
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.
|Condition or disease||Intervention/treatment|
|COVID-19 Pneumonia, Viral Pulmonary Infection||Diagnostic Test: Lung ultrasound|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Bruk av Ultralyd i Evaluering av Pasienter Med Mistenkt COVID-19 Infeksjon i Norge|
|Actual Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2025|
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 Name: Ultrasonography of the lungs
- Mortality [ Time Frame: up to 30 days ]30-day mortality
- Level-of-care [ Time Frame: up to 7 days ]In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.
- In-hospital length of stay [ Time Frame: Up to 30 days ]in days
- Oxygen usage in the emergency department [ Time Frame: Within 24 hours ]
- Emergency department length of stay [ Time Frame: Within 24 hours ]in hours
- Antibiotics usage [ Time Frame: Within 24 hours ]
- Clinical correlation [ Time Frame: Within 3 days ]Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04422691
|Contact: Lars Petter Bjørnsen, MD, PhDfirstname.lastname@example.org|
|Contact: Lars E Næss-Pleymemail@example.com|
|Haukeland universitetssykehus||Not yet recruiting|
|Contact: Rune Bjørneklett, MD, PhD|
|Nordland Hospital||Not yet recruiting|
|Contact: Eirik H Ofstad, MD, PhD|
|Drammen sykehus||Not yet recruiting|
|Contact: Jørn Rasmussen, MD|
|Sørlandet sykehus, Kristiansand||Not yet recruiting|
|Contact: Benedicte Severinsen, MD|
|Akershus University Hospital||Not yet recruiting|
|Contact: Jay Shyamal Chotai, MD|
|Ullevål University Hospital||Not yet recruiting|
|Contact: Anders B Martinsen, MD|
|Sykehuset Telemark HF||Not yet recruiting|
|Contact: Harry Achterberg, MD|
|Stavanger Universitetssjukehus||Not yet recruiting|
|Contact: Øistein Rønneberg Mjelva, MD, PhD|
|St Olavs Hospital||Recruiting|
|Contact: Lars Petter Bjørnsen, MD, PhD firstname.lastname@example.org|
|Principal Investigator:||Lars Petter Bjørnsen, MD, PhD||NTNU/St. Olav's Hospital|