A Prospective Clinical Study to Explore Response to Prone Positioning in ARDS Patients
- Conditions
- Covid19ARDS
- Interventions
- Other: Lung Ultrasound (LUS)
- Registration Number
- NCT04692779
- Lead Sponsor
- Rush University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Adult subjects 18 years and older, diagnosis of ARDS
- endotracheally intubated and receiving assisted mechanical ventilation
- 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
- receive an order for prone positioning.
- Pregnant
- Tracheostomy
- Receiving ECMO
- Palliative care
- Receive prone positioning more than once during intubation in an outside hospital
- Receive invasive ventilation in an outside hospital for more than 72 hours
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intubated ARDS patients undergoing prone positioning Lung Ultrasound (LUS) All intubated ARDS patients undergoing prone positioning will be assessed with LUS before and after prone positioning and before and after placing back in the supine position.
- Primary Outcome Measures
Name Time Method Oxygenation and Lung Ultrasound Score (LUS) 10 months Patients' responses of oxygenation and lung ultrasound score (0 - 36 where 0 = normal lung aeration and 36 = most severe lung consolidation) to prone positioning in the first three prone positioning sessions for ARDS patients.
- Secondary Outcome Measures
Name Time Method COVID-19 ARDS vs non-COVID-19 ARDS 10 months observed lung ultrasound score (0 - 36 where 0 = normal lung aeration and 36 = most severe lung consolidation) differences between patients who respond to prone positioning and those who do not respond among patients with COVID-19 ARDS and non-COVID-19 ARDS.
Trial Locations
- Locations (1)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States