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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04855162
• Other study ID #: 21040601
• Status: Completed
• Start date: July 21, 2021
• Est. completion date: October 23, 2021

Study information

• Verified date: November 2021
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 23, 2021
• Est. primary completion date: October 7, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
Mexico	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Hospital Civil de Guadalajara

Countries where clinical trial is conducted

United States,  Mexico, 

References & Publications (4)

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. — View 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. — View 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. — View 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 co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2/FiO2 pre prone in day 1	Patients' response of oxygenation using SpO2/FiO2	pre prone in day 1
Primary	SpO2/FiO2 post prone in day 1	Patients' response of oxygenation using SpO2/FiO2	post prone in day 1
Primary	SpO2/FiO2 pre prone in day 2	Patients' response of oxygenation using SpO2/FiO2	Pre prone in day 2
Primary	SpO2/FiO2 post prone in day 2	Patients' response of oxygenation using SpO2/FiO2	Post prone in day 2
Primary	SpO2/FiO2 pre prone in day 3	Patients' response of oxygenation using SpO2/FiO2	Pre prone in day 3
Primary	SpO2/FiO2 post prone in day 3	Patients' response of oxygenation using SpO2/FiO2	Post prone in day 3
Primary	Lung Ultrasound Score pre prone in day 1	Patients' response of oxygenation using Lung ultrasound score	Pre prone in day 1
Primary	Lung Ultrasound Score post prone in day 1	Patients' response of oxygenation using Lung ultrasound score	Post prone in day 1
Primary	Lung Ultrasound Score pre prone in day 2	Patients' response of oxygenation using Lung ultrasound score	Pre prone in day 2
Primary	Lung Ultrasound Score post prone in day 2	Patients' response of oxygenation using Lung ultrasound score	Post prone in day 2
Primary	Lung Ultrasound Score pre prone in day 3	Patients' response of oxygenation using Lung ultrasound score	Pre prone in day 3
Primary	Lung Ultrasound Score post prone in day 3	Patients' response of oxygenation using Lung ultrasound score	Post prone in day 3