Clinical trial NCT04855162: Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning
Official title: Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Awake prone
Self prone
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Hospital Civil de Guadalajara
First posted: 2021-04-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: SpO2/FiO2 pre prone in day 1
timeFrame: pre prone in day 1
measure: SpO2/FiO2 post prone in day 1
timeFrame: post prone in day 1
measure: SpO2/FiO2 pre prone in day 2
timeFrame: Pre prone in day 2
measure: SpO2/FiO2 post prone in day 2
timeFrame: Post prone in day 2
measure: SpO2/FiO2 pre prone in day 3
timeFrame: Pre prone in day 3
measure: SpO2/FiO2 post prone in day 3
timeFrame: Post prone in day 3
measure: Lung Ultrasound Score pre prone in day 1
timeFrame: Pre prone in day 1
measure: Lung Ultrasound Score post prone in day 1
timeFrame: Post prone in day 1
measure: Lung Ultrasound Score pre prone in day 2
timeFrame: Pre prone in day 2
measure: Lung Ultrasound Score post prone in day 2
timeFrame: Post prone in day 2
measure: Lung Ultrasound Score pre prone in day 3
timeFrame: Pre prone in day 3
measure: Lung Ultrasound Score post prone in day 3
timeFrame: Post prone in day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: Rush University
name: Jie Li
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.