Urgences - Hôpital Cochin APHP
Paris, 75014, France
NCT Number: NCT04335019
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.
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Notify Me18 year and older
All sexes
Observational
Paris, 75014, France
The practitioners involved at each site are
The data collected under this protocol consists in:
Patients follow-up happens at D5, D15 and 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.
Patients are informed orally (in the event of altered state of consciousness, their close relative present will benefit from this information) that they will be contacted remotely (at D5, D15 and D28) to inquire about their development.
Patients hospitalized in most of the hospitals participating in the research will be offered a daily assessment of their clinical status, an ultrasound within 24-48 hours of the start of hospitalization, two other ultrasounds performed between D5 and D10. A final ultrasound will be performed before leaving the service.
In the event of worsening, a compression ultrasound of the lower limbs and a simple cardiac ultrasound is performed in search of signs of DVT or an acute pulmonary heart on a 4-point compression ultrasound and echocardiography which will be performed in the event of clinical worsening following the inclusion of the following :
The report of the examination will be given on a standardized examination sheet with identification of the patient on each examination + identifier of the clinician operator.
The data will be kept for remote reading by a referent. All these examinations are carried out as part of the management of patients for the treatment of their COVID infection.
Patients are also informed:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: at day 0
Association of pulmonary lesions on ultrasound on D0 classified according to three stages of severity
Time frame: at day 0
The operator's identity and level of expertise will be indicated:
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).
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)
Time frame: at day 5
A search for the occurrence of one of these 3 events
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.
Time frame: at day 15
A search for the occurrence of one of these 3 events
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.
Time frame: at day 28
A search for the occurrence of one of these 3 events
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.
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:
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:
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:
Assistance Publique - Hôpitaux de Paris
Other
Acronym: eChoVid
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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