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CompletedNCT04474236QUICKUpdated Jun 1, 2021

Lung Ultrasound for COVID-19 Initial Triage and Monitoring

An observational study in COVID-19, Acute Respiratory Failure and Triage, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2021-06-01.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
17 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • COVID-19
  • Acute Respiratory Failure
  • Triage
  • Lung Ultrasound
  • CT Scan

Keywords

  • COVID-19
  • Acute Respiratory Failure
  • Triage
  • Lung Ultrasound
  • CT scan
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 25 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pilot study

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • COVID-19 patients

    Adult (\> 18 years) with Proven COVID-19 (specific PCR from respiratory track sample)

    Other: thoracic lung ultrasound

Interventions

  • Otherthoracic lung ultrasound

    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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Day 1

Secondary outcomes

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

    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.

    Time frame: Day 1

  2. mortality

    mortality

    Time frame: Day 28

07

Study locations

1 site
  • University Hospital Toulouse
    Toulouse, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04474236
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Jul 16, 2020
Start date
May 27, 2020
Primary completion
Mar 7, 2021
Completion
Mar 7, 2021
Last update
Jun 1, 2021

Study contacts

Benjamine SARTON, ph
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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