Point-of-care ultrasonography for risk stratification of non-critical suspected COVID-19 patients on admission (POCUSCO): a prospective binational study

  1. François Morin
  2. Delphine Douillet
  3. Jean François Hamel
  4. Dominique Savary
  5. Christophe Aubé
  6. Karim Tazarourte
  7. Kamélia Marouf
  8. Florence Dupriez
  9. Philipe Le Conte
  10. Thomas Flament
  11. Thomas Delomas
  12. Mehdi Taalba
  13. Nicolas Marjanovic
  14. Francis Couturaud
  15. Nicolas Peschanski
  16. Thomas Boishardy
  17. Jérémie Riou
  18. Vincent Dubée
  19. Pierre-Marie Roy

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Abstract

Background

Lung point-of-care ultrasonography (L-POCUS) is highly effective in detecting pulmonary peripheral patterns and may allow early identification of patients who are likely to develop an acute respiratory distress syndrome (ARDS). We hypothesized that L-POCUS performed during the initial examination would identify non-severe COVID-19 patients with a high risk of getting worse.

Methods

POCUSCO was a prospective, multicenter study. Non-critical adult patients who were admitted to the emergency department (ED) for suspected or confirmed COVID-19 were included and had L-POCUS performed within 48 hours following admission. The severity of lung damage was assessed using the L-POCUS score based on 36 points for ARDS. The primary outcome was the rate of patients requiring intubation or who died within 14 days following inclusion.

Results

Among 296 participating patients, 8 (2.7%) had primary outcome. The area under the curve (AUC) of the receiver operating characteristic of L-POCUS was 0.80 [95%CI:0.60-0.94]. The score values which achieved a sensibility > 95% in defining low-risk patients and a specificity > 95% in defining high-risk patients were <1 and ≥16, respectively. The rate of patients with an unfavorable outcome was 0/95 (0%[95%CI:0-3.9]) for low-risk patients (score=0) versus 4/184 (2.17%[95%CI:0.8-5.5]) for intermediate-risk patients (score 1-15) and 4/17 (23.5%[95%CI:11.4-42.4]) for high-risk patients (score ≥16). In patients with confirmed COVID-19 (n=58), the AUC of L-POCUS was 0.97 [95%CI:0.92-1.00].

Conclusions

L-POCUS allows risk-stratification of patients with suspected or confirmed COVID-19. These results should be confirmed in a population with a higher risk of an unfavorable outcome.

Trial registration number

NCT04338100

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  1. ScreenIT

    SciScore for 10.1101/2021.03.09.21253208: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: The protocol was approved by the Ethics Committee CPP Sud-Ouest et Outre-Mer II for France (No. 2020-A00782-37 / 2-20-025 id7566) and the Ethics Committee of the Cliniques Universitaires Saint-Luc for Belgium (No. 2020/14AVR/223).
    Consent: Written informed consent was obtained from all patients.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    All statistical analyzes were performed using STATA, version 14.2; StataCorp; College Station, TX.
    STATA
    suggested: (Stata, RRID:SCR_012763)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Nevertheless, it has some limitations, one of the more important being the low primary endpoint rate. On the basis of the first cohorts of COVID-19 inpatients, we considered a rate of mortality or invasive ventilation requirement of 10%, at the time the protocol was written.[38] It was actually 7% in confirmed COVID-19 patients and only 2.4% in our overall cohort. Several factors may explain this discrepancy: differences in the completeness of testing and case identification, variable thresholds for hospitalization and Intensive Care Unit admission, and improvement in patients’ care.[39] Moreover, only a quarter of participating patients had a positive RT-PCR for SARS-CoV-2, the other patients may have had a minor form of COVID-19 or another less severe disease. Nevertheless, our results are in line with the 1.4% mortality rate and 2.3% rate of patients who underwent invasive mechanical ventilation in the cohort of Guan et al.[4] Finally, in the absence of a derivation model, it is not methodologically justified to assess the calibration of L-POCUS.[18] Another study must be carried out to validate our results on an independent cohort.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04338100Not yet recruitingPoint Of Care UltraSonography for Risk-stratification of COV…

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a protocol registration statement.

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  2. Version published to 10.1101/2021.03.09.21253208v1 on medRxiv