- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04338568
Screening COVID-19 by Point-of-care Lung Ultrasound: a Validation Study (SCOUT)
Accuracy and Inter-observer Variability of Lung Ultrasound in COVID-19 Pneumonia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michiel J Thomeer, MD,PhD
- Phone Number: +3289327171
- Email: michiel.thomeer@zol.be
Study Locations
-
-
Limburg
-
Genk, Limburg, Belgium, 3600
- Recruiting
- Ziekenhuis Oost Limburg
-
Contact:
- Michiel J Thomeer, MD, PhD
- Phone Number: +3289327171
- Email: michiel.thomeer@zol.be
-
Contact:
- Inge Thijs, PhD
- Phone Number: +3289212007
- Email: Inge.Thijs@zol.be
-
Sub-Investigator:
- Marc Daenen, MD
-
Sub-Investigator:
- David Ruttens, MD, PhD
-
Principal Investigator:
- Michiel Thomeer, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: LUS observer 1
The subject will undergo a Lung Ultrasound by observer nr 1
|
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.
|
ACTIVE_COMPARATOR: LUS observer 2
The subject will undergo a Lung Ultrasound by observer nr 2
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of the diagnosis of interstitial syndrome by lung ultrasound
Time Frame: within 2 weeks after first subject included
|
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.
|
within 2 weeks after first subject included
|
Inter-observer variability
Time Frame: within 2 weeks after first subject included
|
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
|
within 2 weeks after first subject included
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michiel Thomeer, MD,PhD, Ziekenhuis Oost-Limburg
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTU2020032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19 Pneumonia
-
Ministry of Health, KuwaitUnknownPneumonia, Viral | Moderate COVID-19 Pneumonia, Severe COVID-19 PneumoniaKuwait
-
Institute of Vaccines and Medical Biologicals,...National Institute of Hygiene and Epidemiology, Vietnam; Hanoi Medical University and other collaboratorsCompletedPneumonia, Viral | COVID-19 Vaccine | COVID-19 Disease | SARS PneumoniaVietnam
-
Mahidol UniversityThe Government Pharmaceutical OrganizationCompletedPneumonia, Viral | Covid-19 | SARS Pneumonia | Covid-19 VaccineThailand
-
Patrick RobinsonRecruitingCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Acute BronchitisUnited States
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
Fundacion Clinica Valle del LiliUniversidad Autonoma de OccidenteCompletedCOVID-19 Pneumonia | COVID-19 (Coronavirus Disease 2019)Colombia
-
Medical University of LodzRecruitingCOVID-19 | COVID-19 Pneumonia | COVID-19 Respiratory InfectionPoland
-
Texas Tech University Health Sciences Center, El...RecruitingPneumonia, Viral | COVID-19 Pneumonia | COVID-19 Respiratory InfectionUnited States
-
Administracion Nacional de Laboratorios e Institutos...RecruitingCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory InfectionArgentina
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory InfectionItaly
Clinical Trials on Lung ultrasound
-
Kasr El Aini HospitalCompletedExta Vascular Lung WaterEgypt
-
Yale UniversityCompletedPneumonia | Pulmonary Edema | DyspneaUnited States
-
Assiut UniversityCompleted
-
University of MilanCompletedLung Cancer | Community Acquired Pneumonia | Pulmonary Embolism | PleuritisItaly
-
Groupe Hospitalier Paris Saint JosephHopital ForcillesActive, not recruitingCOVID-19 | Weaning Failure | ICU Acquired WeaknessFrance
-
Xiangtan Central HospitalActive, not recruitingHeart Failure | Lung UltrasoundChina
-
Cliniques universitaires Saint-Luc- Université...RecruitingInterstitial Lung DiseaseBelgium
-
Phoenix Children's HospitalChildren's Hospital Los Angeles; Baylor Scott and White Health; St. Joseph's... and other collaboratorsEnrolling by invitationBronchopulmonary DysplasiaUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Hospital Vall d'Hebron; Institut Hospital del Mar d'Investigacions MédiquesCompletedHeart Failure | Acute Myocardial InfarctionSpain
-
Centre Hospitalier Universitaire, AmiensCentre Hospitalier de Beauvais; Centre Hospitalier de Clermont; Centre Hospitalier... and other collaboratorsCompleted