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.

Study Overview

• Status: Completed
• Conditions: Covid19

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.

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: 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

Description

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:

1. Pregnant
2. Palliative care

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2/FiO2 pre prone in day 1	Patients' response of oxygenation using SpO2/FiO2	pre prone in day 1
SpO2/FiO2 post prone in day 1	Patients' response of oxygenation using SpO2/FiO2	post prone in day 1
SpO2/FiO2 pre prone in day 2	Patients' response of oxygenation using SpO2/FiO2	Pre prone in day 2
SpO2/FiO2 post prone in day 2	Patients' response of oxygenation using SpO2/FiO2	Post prone in day 2
SpO2/FiO2 pre prone in day 3	Patients' response of oxygenation using SpO2/FiO2	Pre prone in day 3
SpO2/FiO2 post prone in day 3	Patients' response of oxygenation using SpO2/FiO2	Post prone in day 3
Lung Ultrasound Score pre prone in day 1	Patients' response of oxygenation using Lung ultrasound score	Pre prone in day 1
Lung Ultrasound Score post prone in day 1	Patients' response of oxygenation using Lung ultrasound score	Post prone in day 1
Lung Ultrasound Score pre prone in day 2	Patients' response of oxygenation using Lung ultrasound score	Pre prone in day 2
Lung Ultrasound Score post prone in day 2	Patients' response of oxygenation using Lung ultrasound score	Post prone in day 2
Lung Ultrasound Score pre prone in day 3	Patients' response of oxygenation using Lung ultrasound score	Pre prone in day 3
Lung Ultrasound Score post prone in day 3	Patients' response of oxygenation using Lung ultrasound score	Post prone in day 3

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Collaborators: Hospital Civil de Guadalajara
• Investigators: Principal Investigator: Jie Li, Rush University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Actual): October 7, 2021
• Study Completion (Actual): October 23, 2021

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Awake prone; Self prone
• Other Study ID Numbers: 21040601

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No