Official Title
A Prospective Clinical Study to Explore the Mechanism of Patients' Response to Prone Positioning in ARDS Patients, Including COVID-19
Brief Summary

The proposed study will be conducted to investigate the mechanism of patients' responses to prone positioning with coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS utilizing lung ultrasound.

Detailed Description

This is a prospective observational study of adult patients with coronavirus disease 2019
(COVID-19) acute respiratory distress syndrome (ARDS) and non-COVID-19 ARDS who are
intubated, in the prone position and receiving mechanical ventilation in the intensive care
units at Rush University Medical Center. In this study design, we will prospectively enroll
subjects, who fulfill eligibility criteria, to investigate the mechanism of their responses
to the first three prone positioning sessions, utilizing lung ultrasound (LUS). Inclusion
criteria include: adult subjects 18 years and older with a diagnosis of ARDS, endotracheally
intubated and receiving assisted mechanical ventilation, meet criteria for prone positioning
(ratio of arterial oxygen tension to the fraction of inspired oxygen (PaO2/FiO2) of ≤ 150 mm
Hg with ventilator parameters of positive end-expiratory pressure (PEEP) ≥ 10 cm H2O and FiO2
of .60, and order for prone positioning. Patients will be excluded from the study if they
meet the following criteria: pregnant, tracheostomy, receiving extracorporeal membrane
oxygenation (ECMO), palliative care, received prone positioning more than once during
intubation in an outside hospital, or receive invasive ventilation in an outside hospital for
more than 72 hours. Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone
positioning by a trained clinician and will be assessed using a LUS score based on LUS
pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by
a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be
enrolled in the study for 4 weeks in order to observe patient outcomes.

Completed
COVID19
ARDS

Other: Lung Ultrasound (LUS)

Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes.

Eligibility Criteria

Inclusion Criteria:

1. Adult subjects 18 years and older, diagnosis of ARDS

2. endotracheally intubated and receiving assisted mechanical ventilation

3. meet criteria for prone positioning: PaO2/FIO2 (P/F ratio) of ≤ 150 mm Hg with
ventilator parameters of PEEP ≥ 10 cm H2O and FiO2 of .60

4. receive an order for prone positioning.

Exclusion Criteria:

1. Pregnant

2. Tracheostomy

3. Receiving ECMO

4. Palliative care

5. Receive prone positioning more than once during intubation in an outside hospital

6. Receive invasive ventilation in an outside hospital for more than 72 hours

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Rush University Medical Center
Chicago, Illinois, United States

Rush University Medical Center
NCT Number
Keywords
Prone positioning
Lung ultrasound
MeSH Terms
COVID-19