Skip to main content
OpenTrials
Completed

NCT Number: NCT04474236

Lung Ultrasound for COVID-19 Initial Triage and Monitoring

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thoracic lung ultrasound

Other

Patients will be recruited the day of their hospital admission. All patients will be assessed by thoracic Computed Tomography scan then immediately before/after CT scan, patients will be clinically assessed (Q-SOFA, SpiO2/FiO2) and a lung ultrasound evaluation (mean time of evaluation 7 min +/- 3 min; fully respect of COVID-19 barrier measures) will be performed by an investigator. Patients clinical status and outcomes will be extracted from patient's medical file at day 1 and day 28 from patient's admission by investigators blinded from previously recorded lung ultrasound data.

Primary outcomes

  1. Area Under the Curve (AUC) of a predictive model built on LUS and clinical (Q-SOFA, SpiO2/FiO2) data

    Time frame: Day 1

    Area Under the Curve (AUC) of a predictive model at 24h from hospital admission (Favorable vs Unfavorable), built on LUS (12 thoracic regions) and clinical (Q-SOFA, SpiO2/FiO2) data recorded at hospital admission.

Secondary outcomes

  1. Area Under the Curve (AUC) of a predictive model built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data

    Time frame: Day 1

    Area Under the Curve (AUC) of a predictive model at 24h from hospital admission (Favorable vs Unfavorable), built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data recorded at hospital admission.

  2. mortality

    Time frame: Day 28

    mortality

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Use of Lung Ultrasound for COVID-19 Patient's Initial Triage Assessment and Early Monitoring: a Pilot Study

Acronym: QUICK

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2020
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.