The goal of this prospective multi-centre randomised controlled trial is to determine if addition of awake prone positioning to standard oxygen, high flow oxygen therapy and non-invasive ventilation may reduce the rates of endotracheal intubation and mechanical ventilation.
Effectiveness of prone position in mechanically ventilated patients was investigated extensively. During the Covid-19 pandemic a sudden increase in cases of acute respiratory failure, resulted in renewed interest and numerous studies on applying this concept in spontaneously breathing patients and using this in conjunction with less invasive respiratory support. However, evidence form the Covid-19 trials may not be directly extrapolated to other acute respiratory distress causes (for example bacterial pneumonia) as pathology of lung injury is distinctly different. Even though first reports of awake prone positioning were published nearly 30 years ago, but to date there are no prospective randomised trials in adult population treated for acute lung injury unrelated to Covid-19. Existing publications range from case reports (lung transplantation and drowning cases) to small feasibility trials involving 15-20 patients and also neonatal and paediatric populations. Considering that patients with acute lung injury constitute a significant proportion of routine intensive care unit population, results of this study would be highly relevant for the daily practice in intensive care medicine.We are aiming to conduct a prospective multi-centre randomised controlled trial comparing standard care alone with awake prone positioning and standard care in spontaneously breathing patients admitted to Intensive or Intermediate Care Units for acute non-Covid-19 hypoxemic respiratory failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
262
Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania
NOT_YET_RECRUITINGRepublican Vilnius University Hospital
Vilnius, Lithuania
NOT_YET_RECRUITINGVilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
RECRUITINGRate of endotracheal intubation
Incidence of endotracheal intubation in both groups
Time frame: Within 30 days of randomisation
Mortality
Mortality during intensive care unit stay, in hospital, at day 90 and at 1 year
Time frame: Within 1 year of randomisation
Duration of mechanical ventilation
Total number of mechanical ventilation days from endotracheal intubation to discharge from intensive care unit
Time frame: Within 30 days of randomisation
Length of intensive care unit and hospital stay
Total cumulative number of days spent in intensive care unit and hospital
Time frame: Within 30 days of randomisation
One year mortality
Incidence or death during one year of randomisation
Time frame: Within 1 year of randomisation
Health related quality of life
Heath related quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) one year of randomisation
Time frame: Within 1 year of randomisation
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Barking, Havering and Redbridge University Hospitals NHS Trust
London, United Kingdom
NOT_YET_RECRUITING