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NCT Number: NCT04855162

Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning

The primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Civil Fray Antonio Alcalde, Guadalajara, Jalisco, Mexico

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About this study

Lung ultrasound (LUS) has recently gained popularity among the imaging methods to perform bedside assessment of critically ill patients to guide clinical management. LUS is a non-invasive and easy-to-perform procedure that provides precise data on lung aeration, lung recruitment, lung morphology, and lung perfusion. Studies have shown that LUS is a useful tool in monitoring lung reaeration in intubated patients diagnosed with traditional ARDS undergoing prone positioning; however there are mixed findings in terms of the use of LUS in predicting potential prone positioning response. A recent study found that the non-intubated COVID-19 patients who responded to prone positioning had more pronounced disturbances of aeration in posterior regions, however, they only investigated patients' response to the first prone positioning and the information for the patients' outcome is lacking. In our previous study with intubated COVID-19 patients, we found that patients' response to the subsequent prone positioning had higher predictive value than the response to the first prone positioning. Therefore, the primary objective of this study is to explore the physiological mechanism of awake, self proning among patients with acute hypoxemic respiratory failure induced by COVID-19, using LUS in the first three days and explore the predictive value of LUS in patients' outcome.

Who can participate

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

Inclusion criteria

  • Adult subjects 18 years and older,
  • Confirmed COVID-19 diagnosis
  • Acute hypoxemic respiratory failure (SpO2/FiO2 or PaO2/FiO2 <300)
  • Ordered self-prone positioning per medical team

Exclusion criteria

  • Pregnant
  • Palliative care

Treatment and study plan

Primary outcomes

  1. SpO2/FiO2 pre prone in day 1

    Time frame: pre prone in day 1

    Patients' response of oxygenation using SpO2/FiO2

  2. SpO2/FiO2 post prone in day 1

    Time frame: post prone in day 1

    Patients' response of oxygenation using SpO2/FiO2

  3. SpO2/FiO2 pre prone in day 2

    Time frame: Pre prone in day 2

    Patients' response of oxygenation using SpO2/FiO2

  4. SpO2/FiO2 post prone in day 2

    Time frame: Post prone in day 2

    Patients' response of oxygenation using SpO2/FiO2

  5. SpO2/FiO2 pre prone in day 3

    Time frame: Pre prone in day 3

    Patients' response of oxygenation using SpO2/FiO2

  6. SpO2/FiO2 post prone in day 3

    Time frame: Post prone in day 3

    Patients' response of oxygenation using SpO2/FiO2

  7. Lung Ultrasound Score pre prone in day 1

    Time frame: Pre prone in day 1

    Patients' response of oxygenation using Lung ultrasound score

  8. Lung Ultrasound Score post prone in day 1

    Time frame: Post prone in day 1

    Patients' response of oxygenation using Lung ultrasound score

  9. Lung Ultrasound Score pre prone in day 2

    Time frame: Pre prone in day 2

    Patients' response of oxygenation using Lung ultrasound score

  10. Lung Ultrasound Score post prone in day 2

    Time frame: Post prone in day 2

    Patients' response of oxygenation using Lung ultrasound score

  11. Lung Ultrasound Score pre prone in day 3

    Time frame: Pre prone in day 3

    Patients' response of oxygenation using Lung ultrasound score

  12. Lung Ultrasound Score post prone in day 3

    Time frame: Post prone in day 3

    Patients' response of oxygenation using Lung ultrasound score

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Hospital Civil de Guadalajara

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2021
Registry last updated
Nov 15, 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.

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