Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +

NCT04335019 | Completed DMC

• 2 other identifiers: APHP2003902020-A00768-31
• Study Type: observational
• Target: 328
• Locations: 1 country
• Sites: 1

Brief Summary

The recent pandemic due to the SARS-CoV2 results in a pulmonary infection in major symptomatic patients. Because of the large number of patients and the risk of acute respiratory distress syndrome (which seems to occur in almost 5% of patients), there is a real challenge to improve physician ability to screen between patients those who will require specific surveillance and those who can be sent back home. The recent French official recommendation of the French radiology society prescribe that chest X-ray do not have any place in the COVID-19+ management whereas the WHO stipulate that ultrasound machines may be useful for these patients \[1-2\]. Moreover, scattered recent publications tend to stress the interest of quick ultrasound imaging for COVID-19 suspected patients for screening purpose \[2-5\]. The aim of this observational historico-prospective study is to assess the risk of severe clinical outcomes (admission in continuous care unit (USC), invasive respiratory assistance, death) in patients suspected or diagnosed COVID-19+ as a function of initial pulmonary ultrasound abnormalities. These clinical outcomes are assessed through phone calls at D5, D15, M1. The secondary objectives are:

• Assessing the concordance between the severity of pulmonary lesions as detected by pulmonary ultrasound devices and the ones detected by CT-scanner, for patients who will undergo these two examinations.
• Assessing the compared performances in detecting ultrasound pulmonary lesions for patients suspected or diagnosed COVID-19+, between an experimented operator and a newly trained operator.
• Evaluate in suspected or COVID-19 patients, the risk of clinical worsening based on pulmonary ultrasound abnormalities during follow-up of hospitalized patients.
• Evaluate the ultrasound evolution profiles of pulmonary lesions in patients whose clinical evolution is favorable.
• Evaluate the incidence of thromboembolic events in patients who worsen secondarily.

Conditions

2019-nCoV (COVID-19); Interstitial Pneumonia

Keywords

Pulmonary ultrasound; Diagnosis improvement; Screening; 2019-nCoV (COVID-19); Chest CT

Outcome Measures

Primary Outcomes (1)

• Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity

  Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity * There are few B lines at the lung bases * Bi-lateralization of B lines, numerous diffuse and / or curtain sign * Presence of signs of pulmonary consolidation, hepatization of the lung and air bronchogram)

  at day 0

Secondary Outcomes (11)

• Assessment of the agreement between a newly trained operator and an experienced operator of classification in one of the three stages of ultrasound gravity, by Cohen's kappa coefficient.

  at day 0

• Estimate in patients who had a CT-scan on D0, the agreement in the evaluation of the severity of lung lesions via ultrasound vs. CT-scan, by Cohen's kappa coefficient

  at day 0

• Measurement of the cumulative incidence of invasive mechanical ventilation

  at day 5

• Measurement of survival

  at day 5

• Measurement of the cumulative incidence of invasive mechanical ventilation

  at day 15

Interventions

Pulmonary ultrasound OTHER

Pulmonary ultrasound results: quotation in 8 fields (right antero-superior, left antero-superior, right antero-inferior, left antero-inferior, right postero-superior, left postero-superior, right postero-inferior and postero-upper left).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Suspected of COVID-19 infection or having a systematic COVID-19 screening

You may qualify if:

• \> 18 years old
• Suspected of COVID-19 infection or having a systematic COVID-19 screening

You may not qualify if:

• Patients on whom the ultrasonographic examination is not feasible for technical reasons (morbid obesity, thoracic extensive subcutaneous emphysema, absorbent subcutaneous infiltrations, ...)
• Patients with comorbidities justifying priority intensive care, not linked to the COVID-19 condition

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Urgences - Hôpital Cochin APHP

Paris, 75014, France

Location

Related Publications (5)

• The recommendations of the French Radiology Society in the context of COVID-19 [Internet]. [cited 2020 Apr 1]. Available from: http://www.thema-radiologie.fr/actualites/2618/les-recommandations-de-la-societe-francaise-de-radiologie-dans-un-contexte-de-covid-19.html

  BACKGROUND

• WHO | Disease Commodity Packages [Internet]. [cited 2020 Apr 1]. Available from: https://www.who.int/emergencies/what-we-do/prevention-readiness/disease-commodity-packages/en/

  BACKGROUND

• Peng QY, Wang XT, Zhang LN; Chinese Critical Care Ultrasound Study Group (CCUSG). Findings of lung ultrasonography of novel corona virus pneumonia during the 2019-2020 epidemic. Intensive Care Med. 2020 May;46(5):849-850. doi: 10.1007/s00134-020-05996-6. Epub 2020 Mar 12. No abstract available.

  PMID: 32166346 BACKGROUND

• Poggiali E, Dacrema A, Bastoni D, Tinelli V, Demichele E, Mateo Ramos P, Marciano T, Silva M, Vercelli A, Magnacavallo A. Can Lung US Help Critical Care Clinicians in the Early Diagnosis of Novel Coronavirus (COVID-19) Pneumonia? Radiology. 2020 Jun;295(3):E6. doi: 10.1148/radiol.2020200847. Epub 2020 Mar 13. No abstract available.

  PMID: 32167853 BACKGROUND

• Buonsenso D, Pata D, Chiaretti A. COVID-19 outbreak: less stethoscope, more ultrasound. Lancet Respir Med. 2020 May;8(5):e27. doi: 10.1016/S2213-2600(20)30120-X. Epub 2020 Mar 20. No abstract available.

  PMID: 32203708 BACKGROUND

MeSH Terms

Conditions

COVID-19; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mehdi BENCHOUFI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: April 2, 2020
• Primary Completion: May 26, 2020
• Study Completion: May 26, 2020
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

FR (1)