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

NCT ID: NCT04338568

Last Updated: 2020-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-16

Study Completion Date

2020-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Pneumonia Lung Ultrasound

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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LUS observer 1

The subject will undergo a Lung Ultrasound by observer nr 1

Group Type ACTIVE_COMPARATOR

Lung ultrasound

Intervention Type DIAGNOSTIC_TEST

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.

LUS observer 2

The subject will undergo a Lung Ultrasound by observer nr 2

Group Type ACTIVE_COMPARATOR

Lung ultrasound

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Lung ultrasound

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ziekenhuis Oost-Limburg

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Prof. dr. Michiel Thomeer

Prof.Dr.Michiel Thomeer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michiel Thomeer, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

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Ziekenhuis Oost Limburg

Genk, Limburg, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Michiel J Thomeer, MD,PhD

Role: CONTACT

+3289327171

Facility Contacts

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Michiel J Thomeer, MD, PhD

Role: primary

+3289327171

Inge Thijs, PhD

Role: backup

+3289212007

References

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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.

Reference Type BACKGROUND
PMID: 24998675 (View on PubMed)

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.

Reference Type RESULT
PMID: 31346914 (View on PubMed)

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.

Reference Type RESULT
PMID: 32215691 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

View Document

Other Identifiers

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CTU2020032

Identifier Type: -

Identifier Source: org_study_id

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