Clinical trial NCT04474236: Lung Ultrasound for COVID-19 Initial Triage and Monitoring
Official title: Use of Lung Ultrasound for COVID-19 Patient's Initial Triage Assessment and Early Monitoring: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Acute Respiratory Failure
Triage
Lung Ultrasound
CT Scan
Keywords: COVID-19
Acute Respiratory Failure
Triage
Lung Ultrasound
CT scan
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 25
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pilot study

Brief summary: The QUICK study main aim is to assess the predictive value at Day 1, of a model built on lung ultrasound (LUS) and clinical data, both recorded at hospital admission of COVID-19 patients.

Detailed description: Initial triage assessment is the cornerstone of first-line medical management for COVID-19 patients. Only an accurate and fast evaluation of COVID-19 patients respiratory system integrity, can allow optimal treatment care and medical resources attribution. Despite its very large deployment, the use of thoracic Computed Tomography (CT scan) for COVID-19 patients severity assessment is currently debated. Actually CT-scan use in this setting: i) it is associated with risky in/out hospital patient's transport, both in terms of medical management of patient's critical conditions and risk of COVID-19 nosocomial transmission, ii) risks related to x-ray exposure iii) CT-scan is a snapshot of respiratory system integrity and does not provide data that might be used for patient's monitoring. LUS is a non-invasive, non-ionizing, fully bedside imaging tool. Investigators team has previously contributed to the development and validation of LUS for critically ill patient's management. To the extent of our knowledge, there is neither data regarding COVID-19 patient's LUS patterns, nor about the potential link between LUS data, patient's severity and outcome.

The investigators hypothesize that the combined use of LUS and clinical data (Q-SOFA score, SpiO2/FiO2) recorded at COVID-19 patients hospital admission, will allow to accurately predict short-term outcome. The investigators expect to predict at patient's hospital admission, the patient's clinical status at 24h: favorable (spontaneous ventilation with O2 \< 6 l/min) or unfavorable (spontaneous ventilation with O2 \> 6 l/min or under mechanical ventilation).

Eligibility criteria: Inclusion criteria:

* Adult (\> 18 years).
* Proven COVID-19 (specific PCR from respiratory track sample)
* CT scan prescribed by physician in charge, independently of research.
* Patients consent (or surrogate decision maker's consent in case of need).

Exclusion criteria:

* Reduction or cessation of active treatment.
* Patient under guardianship, tutelage measure or judicial protection
* Patient deprived of liberty by judicial order
* No French health insurance.
* Pregnancy or nursing woman.
* Enrolled in another trial evaluating thoracic imaging.

Primary outcomes:
measure: Area Under the Curve (AUC) of a predictive model built on LUS and clinical (Q-SOFA, SpiO2/FiO2) data
timeFrame: Day 1
Secondary outcomes:
measure: Area Under the Curve (AUC) of a predictive model built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data
timeFrame: Day 1
measure: mortality
timeFrame: Day 28
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Benjamine SARTON, ph
role: PRINCIPAL_INVESTIGATOR
References: