Ultrasonography in Norwegian Emergency Department Patient... | NCT04422691

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

NCT04422691

Sponsor

St. Olavs Hospital

Status

Terminated

Last Update Posted

Jun 22, 2021Actual

Enrollment

5Actual

Phase

Not provided

Conditions

COVID-19
Pneumonia, Viral
Pulmonary Infection

Interventions

Lung ultrasound

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of Covid-19 patients

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Jun 15, 2021Actual

Completion Date

Jun 15, 2021Actual

First Submitted Date

Jun 5, 2020

First Submission Date that Met QC Criteria

Jun 6, 2020

First Posted Date

Jun 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2021

Last Update Posted Date

Jun 22, 2021Actual

Name	Class
Haukeland University Hospital	OTHER
Ullevaal University Hospital	OTHER
Nordlandssykehuset HF	OTHER
Sorlandet Hospital HF

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
In-hospital length of stay	in days	Up to 30 days
Oxygen usage in the emergency department		Within 24 hours

Other Outcomes

Measure	Description	Time Frame
Clinical correlation	Clinical correlation between ultrasound findings and vital signs, labs, blood gas and other diagnostic modalities.	Within 3 days

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Petter Bjørnsen, MD, PhD	NTNU/St. Olav's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland universitetssykehus		Bergen			Norway
Nordland Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral
D004630	Emergencies

Ancestor Terms

ID	Term
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

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Browse Branches

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