Construction of a Composite Clinical-echo Score Predictive of a Risk of Short-term Aggravation of Respiratory Impairment in Patients Suspected of Covid-19

NCT04370249 | Completed

• 1 other identifier: RC20_0164
• Study Type: observational
• Target: 313
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome; COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  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

  48 hours post-admission

Secondary Outcomes (6)

• Evaluate the prognostic performance of the VIRUScore on the risk of pulmonary aggravation

  48 hours post-admission

• 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).

  14 days post-admission

• Construction of a decisional algorithm for triage and management of COVID-19 patients.

  14 days post-admission

• 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.

  14 days post-admission

• Evaluate the analytical concordance between the pulmonary ultrasound (LUScore) and the Gold-standard CT-scan (CT score)

  14 days post-admission

Study Arms (1)

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

Interventions

pulmonary ultrasound OTHER

pulmonary ultrasound on admission

Patient with suspected COVID-19 infection

Eligibility Criteria

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

Study Population

The target population for VIRUS corresponds to all patients admitted to Emergency Departments on suspicion of COVID-19 (established by primary care professionals or during regulation by the EMS).

You may qualify if:

• Patients admitted and managed in an emergency department under suspicion of COVID-19 who received a pleuro-pulmonary ultrasound on admission

You may not qualify if:

• Patients admitted and treated in an Emergency Department for suspected COVID-19 but who did not receive a pleuro-pulmonary ultrasound on admission

Sponsors & Collaborators

• Nantes University Hospital: lead
• WINFOCUS-France: collaborator

Study Sites (1)

Chu de Nantes

Nantes, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: April 9, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

FR (1)