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Covid19NCT04855162

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

An observational study of Covid19, run by Rush University Medical Center at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
How many people
74 participants
Where
2 sitesin 2 countries
Study dates
21 Jul 2021to 23 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Pregnant
  • Palliative care

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Rush University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

Mexico1 site

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

Other trials in Mexico

About this study

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.

Conditions
Covid19
Keywords
Awake prone, Self prone
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SpO2/FiO2 pre prone in day 1

    Patients' response of oxygenation using SpO2/FiO2

    Measured: pre prone in day 1

  2. SpO2/FiO2 post prone in day 1

    Patients' response of oxygenation using SpO2/FiO2

    Measured: post prone in day 1

  3. SpO2/FiO2 pre prone in day 2

    Patients' response of oxygenation using SpO2/FiO2

    Measured: Pre prone in day 2

  4. SpO2/FiO2 post prone in day 2

    Patients' response of oxygenation using SpO2/FiO2

    Measured: Post prone in day 2

  5. SpO2/FiO2 pre prone in day 3

    Patients' response of oxygenation using SpO2/FiO2

    Measured: Pre prone in day 3

  6. SpO2/FiO2 post prone in day 3

    Patients' response of oxygenation using SpO2/FiO2

    Measured: Post prone in day 3

  7. Lung Ultrasound Score pre prone in day 1

    Patients' response of oxygenation using Lung ultrasound score

    Measured: Pre prone in day 1

  8. Lung Ultrasound Score post prone in day 1

    Patients' response of oxygenation using Lung ultrasound score

    Measured: Post prone in day 1

  9. Lung Ultrasound Score pre prone in day 2

    Patients' response of oxygenation using Lung ultrasound score

    Measured: Pre prone in day 2

  10. Lung Ultrasound Score post prone in day 2

    Patients' response of oxygenation using Lung ultrasound score

    Measured: Post prone in day 2

  11. Lung Ultrasound Score pre prone in day 3

    Patients' response of oxygenation using Lung ultrasound score

    Measured: Pre prone in day 3

  12. Lung Ultrasound Score post prone in day 3

    Patients' response of oxygenation using Lung ultrasound score

    Measured: Post prone in day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start21 Jul 2021
  3. Primary completion7 Oct 2021
  4. Study completion23 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04855162
Sponsor's protocol ID
21040601
Status last verified
Nov 2021
First submitted
13 Apr 2021
Last updated
15 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Rush University Medical Center at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SpO2/FiO2 pre prone in day 1 (time frame: pre prone in day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04855162, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

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