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Screening COVID-19 by Point-of-care Lung Ultrasound: a Validation Study (SCOUT)

Primary Purpose

COVID-19 Pneumonia, Lung Ultrasound

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Lung ultrasound
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19 Pneumonia focused on measuring accuracy, inter-observer variability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. high probability CT thorax or chest X-ray for viral pneumonia within five days of the day of inclusion
  2. positive COVID-19 nasopharyngeal swab within 10 days of inclusion
  3. 18 years or older
  4. Oxygen saturation of < 93% in ambient air
  5. Signed written informed consent

Exclusion Criteria:

  • Contra-indication for lung ultrasound
  • Other causes of hypoxia or of pulmonary infiltrates on CT thorax or chest X-ray

Sites / Locations

  • Ziekenhuis Oost LimburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LUS observer 1

LUS observer 2

Arm Description

The subject will undergo a Lung Ultrasound by observer nr 1

The subject will undergo a Lung Ultrasound by observer nr 2

Outcomes

Primary Outcome Measures

Accuracy of the diagnosis of interstitial syndrome by lung ultrasound
The diagnostic accuracy of lung ultrasound is more than 90% compared to low-dose CT or chest X-ray for the detection of viral pneumonia in patients with COVID-19 infection.
Inter-observer variability
The interobserver variability by lung ultrasound between the 2 observers for the diagnosis of interstitial syndrome by lung ultrasound is > 0.6 measured by the Kappa score

Secondary Outcome Measures

Full Information

First Posted
April 4, 2020
Last Updated
August 14, 2020
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT04338568
Brief Title
Screening COVID-19 by Point-of-care Lung Ultrasound: a Validation Study
Acronym
SCOUT
Official Title
Accuracy and Inter-observer Variability of Lung Ultrasound in COVID-19 Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
COVID-19 is a rapidly spreading and very contagious disease caused by a novel coronavirus that can lead to respiratory insufficiency. In many patients, the chest radiograph at first presentation be normal, and early low-dose CT-scan is advocated to diagnose viral pneumonia. Lung ultrasound (LUS) has similar diagnostic properties as CT for diagnosing pneumonia. However, it has the advantage that it can be performed at point-of-care, minimizing the need to transfer the patient, reducing the number of health care personnel and equipment that come in contact with the patient and thus potentially decrease the risk of spreading the infection. This study has the objective to examine the accuracy of lung ultrasound in patients with proven COVID-19 pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pneumonia, Lung Ultrasound
Keywords
accuracy, inter-observer variability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with the diagnosis of COVID-19 pneumonia will undergo a lung ultrasound, by two observers each. The findings will be compared with findings on chest x-ray and/or CT thorax. Accuracy and inter-observer variability will be calculated.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LUS observer 1
Arm Type
Active Comparator
Arm Description
The subject will undergo a Lung Ultrasound by observer nr 1
Arm Title
LUS observer 2
Arm Type
Active Comparator
Arm Description
The subject will undergo a Lung Ultrasound by observer nr 2
Intervention Type
Diagnostic Test
Intervention Name(s)
Lung ultrasound
Intervention Description
The lung ultrasound examination consists of two-sided scanning of the anterior and lateral chest wall and is performed with patients in supine or near-to-supine position.
Primary Outcome Measure Information:
Title
Accuracy of the diagnosis of interstitial syndrome by lung ultrasound
Description
The diagnostic accuracy of lung ultrasound is more than 90% compared to low-dose CT or chest X-ray for the detection of viral pneumonia in patients with COVID-19 infection.
Time Frame
within 2 weeks after first subject included
Title
Inter-observer variability
Description
The interobserver variability by lung ultrasound between the 2 observers for the diagnosis of interstitial syndrome by lung ultrasound is > 0.6 measured by the Kappa score
Time Frame
within 2 weeks after first subject included

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: high probability CT thorax or chest X-ray for viral pneumonia within five days of the day of inclusion positive COVID-19 nasopharyngeal swab within 10 days of inclusion 18 years or older Oxygen saturation of < 93% in ambient air Signed written informed consent Exclusion Criteria: Contra-indication for lung ultrasound Other causes of hypoxia or of pulmonary infiltrates on CT thorax or chest X-ray
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michiel J Thomeer, MD,PhD
Phone
+3289327171
Email
michiel.thomeer@zol.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel Thomeer, MD,PhD
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michiel J Thomeer, MD, PhD
Phone
+3289327171
Email
michiel.thomeer@zol.be
First Name & Middle Initial & Last Name & Degree
Inge Thijs, PhD
Phone
+3289212007
Email
Inge.Thijs@zol.be
First Name & Middle Initial & Last Name & Degree
Marc Daenen, MD
First Name & Middle Initial & Last Name & Degree
David Ruttens, MD, PhD
First Name & Middle Initial & Last Name & Degree
Michiel Thomeer, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan
Citations:
PubMed Identifier
24998675
Citation
Ramirez P, Torres A. Should ultrasound be included in the initial assessment of respiratory patients? Lancet Respir Med. 2014 Aug;2(8):599-600. doi: 10.1016/S2213-2600(14)70142-0. Epub 2014 Jul 3. No abstract available.
Results Reference
background
PubMed Identifier
31346914
Citation
Pisani L, Vercesi V, van Tongeren PSI, Lagrand WK, Leopold SJ, Huson MAM, Henwood PC, Walden A, Smit MR, Riviello ED, Pelosi P, Dondorp AM, Schultz MJ; Lung Ultrasound Consortium. The diagnostic accuracy for ARDS of global versus regional lung ultrasound scores - a post hoc analysis of an observational study in invasively ventilated ICU patients. Intensive Care Med Exp. 2019 Jul 25;7(Suppl 1):44. doi: 10.1186/s40635-019-0241-6.
Results Reference
result
PubMed Identifier
32215691
Citation
Li K, Fang Y, Li W, Pan C, Qin P, Zhong Y, Liu X, Huang M, Liao Y, Li S. CT image visual quantitative evaluation and clinical classification of coronavirus disease (COVID-19). Eur Radiol. 2020 Aug;30(8):4407-4416. doi: 10.1007/s00330-020-06817-6. Epub 2020 Mar 25.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.castoredc.com/

Learn more about this trial

Screening COVID-19 by Point-of-care Lung Ultrasound: a Validation Study

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