Construction of a Composite Clinical-echo Score Predictive of a Risk of Short-term Aggravation of Respiratory Impairment in Patients Suspected of Covid-19 (VIRUS)
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|ClinicalTrials.gov Identifier: NCT04370249|
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : November 10, 2020
With the influx of patients suspected of Covid-19 and the limited number of hospital beds, there is a need for sensitive triage to detect patients at risk of pulmonary complications and therefore requiring hospitalization, but also specific triage to safely discharge patients without risk factors or signs of clinical or ultrasound severity. The use of pulmonary ultrasound in addition to clinical assessment seems appropriate. Indeed, it allows early detection of signs of pneumopathy which, in the current context, most often correspond to Covid-19. These signs include B-lines, which indicate interstitial pulmonary oedema, and an anfractuous and thickened pleural line, or even centimetric parenchymal condensations with a low level of pleural effusion. Conversely, the presence of a medium to large pleural effusion is not very suggestive of the diagnosis of Covid-19. In addition, a lung ultrasound score has been developed and validated to assess the severity of acute respiratory distress and predict the occurrence of acute respiratory distress syndrome. It is based on the performance of a 12-point (6 per hemi-thorax) pulmonary ultrasound with the collection of the presence of B-lines, condensation or pleural effusion. In the hands of a trained operator, this examination takes only a few minutes.
The aim of the study is to develop a score based on clinical and ultrasound evidence to allow early and safer referral than that based on clinical evidence alone. To do this, the study will retrospectively collect clinical and lung ultrasound data from departments that use this technique on a daily basis.
|Condition or disease||Intervention/treatment|
|Acute Respiratory Distress Syndrome COVID-19||Other: pulmonary ultrasound|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Construction of a Composite Clinical-echo Score Predictive of a Risk of Short-term Aggravation of Respiratory Impairment in Patients Suspected of Covid-19|
|Actual Study Start Date :||April 9, 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Patient with suspected COVID-19 infection
Patients admitted and managed in an emergency department under suspicion of COVID-19 infection who received a pleuro-pulmonary ultrasound on admission
Other: pulmonary ultrasound
pulmonary ultrasound on admission
- Construction of a composite clinical-echo score (VIRUScore) predictive of risk of worsening respiratory impairment in COVID-19 adult patients admitted to the Emergency Department [ Time Frame: 48 hours post-admission ]Multivariate model predictive of clinical worsening of respiratory impairment within 48 hours post-admission : intubation, oxygenotherapy, need of vasoactive drugs, worsening of state,age, gender, body surface, LUScore (pulmonary ultrasound), FiO2, need of ventral decubitus, risk factor (obesity, asthma...), time from the beginning of the first symptoms
- Evaluate the prognostic performance of the VIRUScore on the risk of pulmonary aggravation [ Time Frame: 48 hours post-admission ]Sensitivity, specificity, positive predictive value, negative predictive value of VIRUScore on risk of pulmonary aggravation
- Evaluate the prognostic performance of the VIRUScore on the risk of severe pulmonary aggravation defined by resuscitation admission and/or death at D14 (sensitivity, specificity, positive predictive value, negative predictive value). [ Time Frame: 14 days post-admission ]Sensitivity, specificity, positive predictive value, negative predictive value of VIRUScore on the risk of severe pulmonary aggravation defined by resuscitation admission and/or death.
- Construction of a decisional algorithm for triage and management of COVID-19 patients. [ Time Frame: 14 days post-admission ]Research of VIRUScore cut-off values maximizing the negative predictive value and construction of a decisional algorithm maximizing returns home and transfers to non-specialized hospitals or clinics without loss of individual chance.
- Search for "ultrasound signature" (lung fields and/or severity of involvement) associated with mild (return home) vs. moderate (oxygen therapy) vs. severe (resuscitation/death) clinical forms. [ Time Frame: 14 days post-admission ]Search for "Ultrasound signature" (lung fields and/or severity of damage) associated with mild vs. moderate (oxygen therapy) vs. severe (resuscitation/death) clinical forms.
- Evaluate the analytical concordance between the pulmonary ultrasound (LUScore) and the Gold-standard CT-scan (CT score) [ Time Frame: 14 days post-admission ]Diagnostic concordance of the LUScore and CT score with the severity grades defined by the French Radiology Society
- Construction of a score predictive of aggravation in the sub-population of patients returned home [ Time Frame: 14 days post-admission ]Predictive Score for Aggravation in Patients Returned Home
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): NCT04370249
|Contact: Philippe LE CONTE, MD-PHD||02 40 08 39 email@example.com|
|Contact: Philippe PES, MD|
|Chu de Nantes||Recruiting|
|Contact: Philippe LE CONTE|