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

Completed

• Conditions: Covid19

• Registration Number: NCT04855162
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-22
• Study Start: 2021-07-21
• Primary Completion: 2021-10-07
• Study Completion: 2021-10-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (2)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Hospital Civil Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico