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

NCT04422691 | Terminated

• 1 other identifier: REK129805
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 9

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.

Conditions

COVID-19; Pneumonia, Viral; Pulmonary Infection

Keywords

Ultrasonography; Norway; Emergency Department; Emergency Physicians

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• In-hospital length of stay

  Up to 30 days

• Oxygen usage in the emergency department

  Within 24 hours

• Emergency department length of stay

  Within 24 hours

• Antibiotics usage

  Within 24 hours

Other Outcomes (1)

• Clinical correlation

  Within 3 days

Study Arms (1)

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

Interventions

Lung ultrasound DIAGNOSTIC_TEST

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.

Also known as: Ultrasonography of the lungs

Covid-19 suspected

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Haukeland University Hospital: collaborator
• Ullevaal University Hospital: collaborator
• Nordlandssykehuset HF: collaborator
• Sorlandet Hospital HF: collaborator
• Drammen sykehus: collaborator
• Sykehuset Telemark: collaborator
• Helse Stavanger HF: collaborator
• University Hospital, Akershus: collaborator

Study Sites (9)

Haukeland universitetssykehus

Bergen, Norway

Location

Nordland Hospital

Bodø, Norway

Location

Drammen sykehus

Drammen, Norway

Location

Sørlandet sykehus, Kristiansand

Kristiansand, Norway

Location

Akershus University Hospital

Oslo, Norway

Location

Ullevål University Hospital

Oslo, Norway

Location

Sykehuset Telemark HF

Skien, Norway

Location

Stavanger Universitetssjukehus

Stavanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

COVID-19; Pneumonia, Viral; Emergencies

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars Petter Bjørnsen, MD, PhD

  NTNU/St. Olav's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: July 1, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (9)