Point Of Care UltraSonography for Risk-stratification of COVID-19 Patients (POCUSCO)

March 7, 2022 updated by: University Hospital, Angers

Point Of Care UltraSonography to Perform Risk-stratification of Patients With Suspected or Confirmed COVID-19 - POCUSCO Study

COVID-19 pandemic has developed worldwide in less than 4 months. While most patients have a mild or uncomplicated disease (80%), approximately 15% need hospital care and 5% intensive care. Severe cases are characterized by pulmonary involvement which may progress to acute respiratory distress syndrome (ARDS). Early identification of patients who are likely to get worse is therefore a major issue.

While, chest X-ray has poor diagnostic performances, pulmonary computed tomography (CT scan) seems very sensitive (97%) and quite specific of COVID-19. Sub-pleural bilateral ground-glass pattern can precede the positivity of RT-PCR for SARS-CoV-2. CT scan is now considered as the best imaging test to assess COVID-19 patients and is recommended as first-line diagnosis tool by the French Society of Radiology (SFR). However, performing CT scan in all or many patients with suspected COVID-19 may result in radiology department overload, especially, taking into account bio-cleaning between patients. Moreover, CT scan may lead to adverse effects including induced cancer due to the cumulative diagnostic irradiation.

Chest ultrasonography may be an alternative to CT scan. It is a simple, non-invasive, non-irradiating, inexpensive and available at the point of care (POCUS). Most of emergency physicians and many other specialists (pneumologists, infectious disease or intensive care physicians) are trained to perform chest POCUS and use it in their everyday practice. Multiple studies have demonstrated its superiority to chest X-ray for the detection of pneumonia. In ARDS, a scoring has been developed and has shown good correlation with mortality. POCUS is very effective in detecting peripheral patterns and seems appropriate to explore COVID-19 patients.

Previous studies suggest its interest in SARSCov2 infections for initial patient assessment and identification of lung damage. However, its performances have never been scientifically evaluated to date.

Our main hypothesis is that point of care lung ultrasonography performed during the initial examination may identify high-risk COVID-19 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients consulting in the emergeny department of participating centres for suspected or confirmed COVID-19 are checked for inclusion and non-inclusion criteria and asked for study participation.

Including patients have point-of-care lung ultrasonography (POCUS) performed within 48 hours following ED admission. The severity of lung damage is assessed using the lung ultrasonography score on 36 points for ARDS (POCUS score).

Apart POCUS score assessment, patients are managed as usual.

If a chest CT scan is performed, its result is collected and, in particular, the quantification of the extent of pulmonary lesions in percentage from 0 to 100%, carried out according to the recommendations of the French Society of Radiology.

For hospitalized patients, if possible, a second chest ultrasonography is performed on Day 5 +/- 3. The extent of lung damage is assessed by the POCUS score.

A follow-up is carried out on day 14 (D14) and the patient's status according to the "Ordinal Scale for Clinical Improvement" for COVID-19 from WHO is recorded.

Study Type

Observational

Enrollment (Actual)

307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, BE 1200
        • Florence DUPRIEZ
  • France
      • Angers, France, 49933
        • MORIN François
      • Brest, France, 29200
        • COUTURAUD Francis
      • Cholet, France, 49325
        • BAUDIN Laure
      • Lyon, France, 69002
        • TAZAROURTE Karim
      • Nantes, France, 44093
        • LE CONTE Philippe
      • Poitiers, France, 86000
        • MARJANOVIC Nicolas
      • Rennes, France, 35033
        • SOULAT Louis
      • Rouen, France, 76000
        • JOLY Luc-Marie
      • Saint-Lô, France, 50000
        • DELOMAS Thomas
      • Tours, France, 37044
        • FLAMENT Thomas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults patients consulting emergency department with non-severe suspected or confirmed SARS-CoV-2 infection (COVID-19)

Description

Inclusion Criteria:

  • Patient with COVID-19 confirmed by positive RT-PCR or considered as probable by the in-charge physician,
  • ≥18 years old,
  • Not requiring respiratory assistance and/or other intensive care
  • Not subject to a limitation of active therapeutics

Exclusion Criteria:

  • History of pneumonectomy
  • Any reason making chest ultrasonography impossible
  • Any reason making 14-day follow-up impossible
  • Patient opposition to research participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chest Ultrasound
Only one arm, all included patients having chest ultrasonography.
Procedure: Follow-up at 14 days
Point of care chest ultrasonography and 14-day follow-up to assess the evolution of the infection and care requirement (invasive ventilation or death)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of unfavourable outcome at D14
Time Frame: 14 days

To assess, in patients with confirmed or probable SARS-CoV-2 infection, chest ultrasonography capacity, using the POCUS score for ARDS, to identify patients with unfavourable outcome at D14.

Unfavourable outcome is defined by intubation with mechanical ventilation requirement or death (Stage ≥ 6 on "Ordinal Scale for Clinical Improvement" of the World Health Organization) within 14 days of inclusion.

We will determine the 95% confidence interval of the AUC of the ROC curve and consider POCUS capacity as clinically relevant if the lower limit of the 95% confidence interval is at least 0.7.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of unfavourable outcome over time
Time Frame: 14 days

To evaluate, in patients with a confirmed or probable SARS-CoV-2 infection, whether POCUS score performances vary as a function of time, between D1 and D14, and, if so, until which time horizon its performances are clinically relevant.

In this purpose, we will determine the time period for which the lower limit of the 95% confidence interval of the AUC of the POCUS score ROC curve is at least 0.7.
14 days
Risk-stratification threshold values
Time Frame: 14 days

To identify the threshold values of POCUS score to perform risk-stratification in three groups of patients:

  1. low-risk patients,
  2. intermediate-risk patients,
  3. high-risk patients.

In this purpose, we will determine two threshold values on the inflection points of the ROC curve:

  • maximizing the specificity for a sensitivity of at least 95%,
  • maximizing the sensitivity for a specificity of at least 95%.
14 days
Adding value of POCUS score to previous risk-stratification clinical rules
Time Frame: 14 days

To study the impact of adding the result of POCUS evaluation to several risk-stratification clinical rules for pulmonary infection or sepsis: qSOFA, CRB 65 and CURB 65

In this purpose, we will attribute 0, 1 or 2 points to POCUS score according to the predefined threshold values and will assess :

  • sensitivities of qSOFA with and without addition of POCUS score result,
  • specificities of qSOFA with and without addition of POCUS score result;
  • sensitivities of CRB 65 with and without addition of POCUS score result,
  • specificities of CRB 65 with and without addition of POCUS score result;
  • sensitivities of CRB 65 with and without addition of POCUS score result,
  • specificities of CRB 65 with and without addition of POCUS score result.
14 days
POCUS score and patient clinical status at D14
Time Frame: 14 days

To assess, the capacity of POCUS score at D0 to predict patient clinical status at D14

In this purpose, we will determine the correlation coefficient between the POCUS score at D0 and the clinical status of patients at day 14 according to the WHO Ordinal Scale for Clinical Improvement for COVID-19 patients.
14 days
POCUS and CT scan correlation
Time Frame: 14 days

To study the correlation between POCUS and CT scan assessment of lung damage.

In this purpose, we will determine the intra-class correlation coefficient between POCUS assessment according to the number of affected areas among 12 and CT scan assessment according to the quantification proposed by the French Society of Radiology: 0 - normal; 1 - minor (< 10%), 2 - moderate (10-25%), 3 - important (25-50%), 4 - severe (50-75%), 5 - critical (> 75%)
14 days
POCUS versus CT scan risk-stratification performances
Time Frame: 14 days

To compare the diagnostic performances of POCUS with that of chest computed tomography to identify patients with unfavourable outcome.

In this purpose, we will compare the AUC of the ROC curves of POCUS score and CT scan quantification of lung damage to identify patients with unfavourable outcome (intubation and mechanical ventilation requirement or death)
14 days
POCUS score evolution performances
Time Frame: 14 days

To evaluate, in the subgroup of hospitalized patients having a second chest ultrasonography at Day 5 +/- 3 of inclusion, the performances of the evolution of the POCUS score between the first and the second assessment to identify patients with unfavourable outcome.

In this purpose, we will calculate the delta between the first and second POCUS score and determine the AUC of the ROC curve and its 95% confidence interval.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Philippe LE CONTE, Pr, University Hospital of Nantes
  • Principal Investigator: Thomas FLAMENT, Dr, University Hospital of Tours
  • Principal Investigator: Louis SOULAT, Pr, University Hospital of Rennes
  • Principal Investigator: Nicolas MARJANOVIC, Dr, University Hospital of Poitiers
  • Principal Investigator: Francis COUTURAUD, Dr, University Hospital of Brest
  • Principal Investigator: Laure BAUDIN, Dr, Hospital of Cholet
  • Principal Investigator: Karim TAZAROURTE, Pr, Hospices Civils de Lyon (University Hospital of Lyon)
  • Principal Investigator: Thomas DELOMAS, Dr, Hospital of Saint-Lô
  • Principal Investigator: Luc-Marie JOLY, Pr, University Hospital, Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2020

Primary Completion (Actual)

June 5, 2020

Study Completion (Actual)

June 23, 2020

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 4, 2020

First Posted (Actual)

April 8, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A00782-37

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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