Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335019
Recruitment Status : Completed
First Posted : April 6, 2020
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
2019-nCoV (COVID-19) Interstitial Pneumonia Other: Pulmonary ultrasound

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 328 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interest of the Use of Pulmonary Ultrasound in the Referral of Patients With or Suspected COVID-19 +
Actual Study Start Date : April 2, 2020
Actual Primary Completion Date : May 26, 2020
Actual Study Completion Date : May 26, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Pulmonary ultrasound
    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).


Primary Outcome Measures :
  1. Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity [ Time Frame: at day 0 ]

    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)


Secondary Outcome Measures :
  1. 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. [ Time Frame: at day 0 ]

    The operator's identity and level of expertise will be indicated:

    • emergency physicians who are experts in pulmonary ultrasound
    • newly trained doctors who have received 30 minutes quick training in the fundamentals of pulmonary ultrasound.

    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).


  2. 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 [ Time Frame: at day 0 ]

    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).

    Results of the chest scanner: typical COVID-19 and extent of the damage (minimal, moderate, severe)


  3. Measurement of the cumulative incidence of invasive mechanical ventilation [ Time Frame: at day 5 ]

    A search for the occurrence of one of these 3 events

    • Addressing in intensive care units
    • Mechanical ventilation
    • Death. In the event of notification of death, the date of occurrence will be indicated.

  4. Measurement of survival [ Time Frame: at day 5 ]
    Patients follow-up happens at D5 through phone call. After verifying their identity using the initials entered and their date of birth, the patient or the referring person in the medical file is asked where the patient is currently (home, non ICU department, ICU department) and whether the patient is in respiratory assistance (invasive or not). In the event of notification of death, the date of occurrence will be indicated.

  5. Measurement of the cumulative incidence of invasive mechanical ventilation [ Time Frame: at day 15 ]

    A search for the occurrence of one of these 3 events

    • Addressing in intensive care units
    • Mechanical ventilation
    • Death. In the event of notification of death, the date of occurrence will be indicated.

  6. Measurement of survival [ Time Frame: at day 15 ]
    Patients follow-up happens at D15 through phone call. After verifying their identity using the initials entered and their date of birth, the patient or the referring person in the medical file is asked where the patient is currently (home, non ICU department, ICU department) and whether the patient is in respiratory assistance (invasive or not). In the event of notification of death, the date of occurrence will be indicated.

  7. Measurement of the cumulative incidence of invasive mechanical ventilation [ Time Frame: at day 28 ]

    A search for the occurrence of one of these 3 events

    • Addressing in intensive care units
    • Mechanical ventilation
    • Death. In the event of notification of death, the date of occurrence will be indicated.

  8. Measurement of survival [ Time Frame: at day 28 ]
    Patients follow-up happens at D28 through phone call. After verifying their identity using the initials entered and their date of birth, the patient or the referring person in the medical file is asked where the patient is currently (home, non ICU department, ICU department) and whether the patient is in respiratory assistance (invasive or not). In the event of notification of death, the date of occurrence will be indicated.

  9. Association of the worsening of pulmonary lesions with the ultrasound [ Time Frame: Within 48 hours of arrival in the service ]

    The kinetics of evolution of the pulmonary lesions with the favorable clinical evolution follow theses events:

    • stopping oxygen therapy
    • discharge from hospital
    • Presence of signs of DVT or an acute pulmonary heart on 4-point compression ultrasound and echocardiography

  10. Association of the worsening of pulmonary lesions with the ultrasound [ Time Frame: Between the 5th and 10 days of hospitalization ]

    The kinetics of evolution of the pulmonary lesions with the favorable clinical evolution follow theses events:

    • stopping oxygen therapy
    • discharge from hospital
    • Presence of signs of DVT or an acute pulmonary heart on 4-point compression ultrasound and echocardiography

  11. Association of the worsening of pulmonary lesions with the ultrasound [ Time Frame: just before discharge from hospital or in case of worsening ]

    The kinetics of evolution of the pulmonary lesions with the favorable clinical evolution follow theses events:

    • stopping oxygen therapy
    • discharge from hospital
    • Presence of signs of DVT or an acute pulmonary heart on 4-point compression ultrasound and echocardiography



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Suspected of COVID-19 infection or having a systematic COVID-19 screening
Criteria

Inclusion criteria :

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

Exclusion criteria :

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335019


Locations
Layout table for location information
France
Urgences - Hôpital Cochin APHP
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Mehdi BENCHOUFI, MD Assistance Publique - Hôpitaux de Paris
Publications:
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04335019    
Other Study ID Numbers: APHP200390
2020-A00768-31 ( Other Identifier: IDRCB )
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pulmonary ultrasound
Diagnosis improvement
Screening
2019-nCoV (COVID-19)
Chest CT
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Lung Diseases, Interstitial
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases