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CompletedNCT04855162Updated Nov 15, 2021

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

An observational study in Covid19, sponsored by Rush University Medical Center. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-15.

Sponsored by Rush University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
74
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Covid19

Keywords

  • Awake prone
  • Self prone
03

In context

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patients with acute hypoxemic respiratory failure due to COVID-19 who are admitted at Rush University Medical Center

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Pregnant
  2. Palliative care
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
74 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. SpO2/FiO2 pre prone in day 1

    Patients' response of oxygenation using SpO2/FiO2

    Time frame: pre prone in day 1

  2. SpO2/FiO2 post prone in day 1

    Patients' response of oxygenation using SpO2/FiO2

    Time frame: post prone in day 1

  3. SpO2/FiO2 pre prone in day 2

    Patients' response of oxygenation using SpO2/FiO2

    Time frame: Pre prone in day 2

  4. SpO2/FiO2 post prone in day 2

    Patients' response of oxygenation using SpO2/FiO2

    Time frame: Post prone in day 2

  5. SpO2/FiO2 pre prone in day 3

    Patients' response of oxygenation using SpO2/FiO2

    Time frame: Pre prone in day 3

  6. SpO2/FiO2 post prone in day 3

    Patients' response of oxygenation using SpO2/FiO2

    Time frame: Post prone in day 3

  7. Lung Ultrasound Score pre prone in day 1

    Patients' response of oxygenation using Lung ultrasound score

    Time frame: Pre prone in day 1

  8. Lung Ultrasound Score post prone in day 1

    Patients' response of oxygenation using Lung ultrasound score

    Time frame: Post prone in day 1

  9. Lung Ultrasound Score pre prone in day 2

    Patients' response of oxygenation using Lung ultrasound score

    Time frame: Pre prone in day 2

  10. Lung Ultrasound Score post prone in day 2

    Patients' response of oxygenation using Lung ultrasound score

    Time frame: Post prone in day 2

  11. Lung Ultrasound Score pre prone in day 3

    Patients' response of oxygenation using Lung ultrasound score

    Time frame: Pre prone in day 3

  12. Lung Ultrasound Score post prone in day 3

    Patients' response of oxygenation using Lung ultrasound score

    Time frame: Post prone in day 3

07

Study locations

2 sites
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • Hospital Civil Fray Antonio Alcalde
    Guadalajara, Jalisco 44280, Mexico
08

References and documents

Publications

  • Langer T, Brioni M, Guzzardella A, Carlesso E, Cabrini L, Castelli G, Dalla Corte F, De Robertis E, Favarato M, Forastieri A, Forlini C, Girardis M, Grieco DL, Mirabella L, Noseda V, Previtali P, Protti A, Rona R, Tardini F, Tonetti T, Zannoni F, Antonelli M, Foti G, Ranieri M, Pesenti A, Fumagalli R, Grasselli G; PRONA-COVID Group. Prone position in intubated, mechanically ventilated patients with COVID-19: a multi-centric study of more than 1000 patients. Crit Care. 2021 Apr 6;25(1):128. doi: 10.1186/s13054-021-03552-2. PubMed 33823862 ↗
  • Wang XT, Ding X, Zhang HM, Chen H, Su LX, Liu DW; Chinese Critical Ultrasound Study Group (CCUSG). Lung ultrasound can be used to predict the potential of prone positioning and assess prognosis in patients with acute respiratory distress syndrome. Crit Care. 2016 Nov 30;20(1):385. doi: 10.1186/s13054-016-1558-0. PubMed 27899151 ↗
  • Avdeev SN, Nekludova GV, Trushenko NV, Tsareva NA, Yaroshetskiy AI, Kosanovic D. Lung ultrasound can predict response to the prone position in awake non-intubated patients with COVID-19 associated acute respiratory distress syndrome. Crit Care. 2021 Jan 25;25(1):35. doi: 10.1186/s13054-021-03472-1. No abstract available. PubMed 33494771 ↗
  • Weiss TT, Cerda F, Scott JB, Kaur R, Sungurlu S, Mirza SH, Alolaiwat AA, Kaur R, Augustynovich AE, Li J. Prone positioning for patients intubated for severe acute respiratory distress syndrome (ARDS) secondary to COVID-19: a retrospective observational cohort study. Br J Anaesth. 2021 Jan;126(1):48-55. doi: 10.1016/j.bja.2020.09.042. Epub 2020 Oct 10. PubMed 33158500 ↗
  • Ibarra-Estrada M, Gamero-Rodriguez MJ, Garcia-de-Acilu M, Roca O, Sandoval-Plascencia L, Aguirre-Avalos G, Garcia-Salcido R, Aguirre-Diaz SA, Vines DL, Mirza S, Kaur R, Weiss T, Guerin C, Li J. Lung ultrasound response to awake prone positioning predicts the need for intubation in patients with COVID-19 induced acute hypoxemic respiratory failure: an observational study. Crit Care. 2022 Jun 27;26(1):189. doi: 10.1186/s13054-022-04064-3. PubMed 35761404 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04855162
Lead sponsor
Rush University Medical Center
Collaborators
Hospital Civil de Guadalajara
Responsible party
Jie Li (Associate Professor, Rush University Medical Center) — Principal investigator
First posted
Apr 22, 2021
Start date
Jul 21, 2021
Primary completion
Oct 7, 2021
Completion
Oct 23, 2021
Last update
Nov 15, 2021

Study contacts

Jie Li
principal investigator · Rush University

Oversight

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

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

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