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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04422691
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : November 25, 2020
Sponsor:
Collaborators:
Haukeland University Hospital
Ullevaal University Hospital
Nordlandssykehuset HF
Sorlandet Hospital HF
Drammen sykehus
Sykehuset Telemark
Helse Stavanger HF
University Hospital, Akershus
Information provided by (Responsible Party):
St. Olavs Hospital

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.


Condition or disease Intervention/treatment
COVID-19 Pneumonia, Viral Pulmonary Infection Diagnostic Test: Lung ultrasound

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: Ultrasonography of the lungs




Primary Outcome Measures :
  1. Mortality [ Time Frame: up to 30 days ]
    30-day mortality

  2. Level-of-care [ Time Frame: up to 7 days ]
    In-hospital treatment level, e.g. discharge from ED, observational unit, ward, ICU.


Secondary Outcome Measures :
  1. In-hospital length of stay [ Time Frame: Up to 30 days ]
    in days

  2. Oxygen usage in the emergency department [ Time Frame: Within 24 hours ]
  3. Emergency department length of stay [ Time Frame: Within 24 hours ]
    in hours

  4. Antibiotics usage [ Time Frame: Within 24 hours ]

Other Outcome Measures:
  1. 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
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Lars Petter Bjørnsen, MD, PhD +4793212617 lars.p.b.w.bjornsen@ntnu.no
Contact: Lars E Næss-Pleym lars.eide.ness@stolav.no

Locations
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Norway
Haukeland universitetssykehus Not yet recruiting
Bergen, Norway
Contact: Rune Bjørneklett, MD, PhD         
Nordland Hospital Not yet recruiting
Bodø, Norway
Contact: Eirik H Ofstad, MD, PhD         
Drammen sykehus Not yet recruiting
Drammen, Norway
Contact: Jørn Rasmussen, MD         
Sørlandet sykehus, Kristiansand Not yet recruiting
Kristiansand, Norway
Contact: Benedicte Severinsen, MD         
Akershus University Hospital Not yet recruiting
Oslo, Norway
Contact: Jay Shyamal Chotai, MD         
Ullevål University Hospital Not yet recruiting
Oslo, Norway
Contact: Anders B Martinsen, MD         
Sykehuset Telemark HF Not yet recruiting
Skien, Norway
Contact: Harry Achterberg, MD         
Stavanger Universitetssjukehus Not yet recruiting
Stavanger, Norway
Contact: Øistein Rønneberg Mjelva, MD, PhD         
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Lars Petter Bjørnsen, MD, PhD       lars.p.b.w.bjornsen@ntnu.no   
Sponsors and Collaborators
St. Olavs Hospital
Haukeland University Hospital
Ullevaal University Hospital
Nordlandssykehuset HF
Sorlandet Hospital HF
Drammen sykehus
Sykehuset Telemark
Helse Stavanger HF
University Hospital, Akershus
Investigators
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Principal Investigator: Lars Petter Bjørnsen, MD, PhD NTNU/St. Olav's Hospital
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT04422691    
Other Study ID Numbers: REK129805
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Ultrasonography
Norway
Emergency Department
Emergency Physicians
Additional relevant MeSH terms:
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Infection
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases