Hypoxemia, Respiratory Failure
Conditions
Keywords
Awake prone, Respiratory failure, ARDS, Hypoxaemia
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAwake prone position (APP)
Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.
Sponsors
Vilnius University Hospital Santaros Klinikos
Vilnius University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
By the nature of the awake prone intervention, it will not be possible to blind clinicians; however, interventions will be blinded to data analysts and outcome assessors.
Intervention model description
Participants will be allocated to the awake prone or standard care groups on a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients admitted to intensive care unit for acute hypoxemic respiratory failure. * Acute hypoxemic respiratory failure is defined by respiratory rate ≥25 breaths/min, and partial pressure of oxygen in the arterial blood (PaO2)/fraction of inspired oxygen (FiO2) ≤300 mm Hg or oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) ratio \<235 while spontaneously breathing under standard oxygen with oxygen flow rate of at least 10 L/min, high flow oxygen therapy or non-invasive ventilation. For patients under standard oxygen, FiO2 is calculated according to the following formula: FiO2=0.21 + 0.03 per litre of supplemental oxygen. * Informed consent
Exclusion criteria
* impaired consciousness - Glasgow coma score \<14; * inability to cooperate or prone position intolerance; * immediate indications for endotracheal intubation; * patients with do-not-intubate order at time of inclusion; * patients with contraindication to high flow oxygen therapy (HFOT) or non-invasive ventilation (NIV); * Partial pressure of carbon dioxide (PaCO2) above 50 mm Hg and quantitative measure of the acidity (pH) \<7,3; * vasopressor dose \>0.3 µg/kg/min of norepinephrine-equivalent to maintain systolic blood pressure \>90 mmHg; * Covid-19 positive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of endotracheal intubation | Within 30 days of randomisation | Incidence of endotracheal intubation in both groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Within 1 year of randomisation | Mortality during intensive care unit stay, in hospital, at day 90 and at 1 year |
| Duration of mechanical ventilation | Within 30 days of randomisation | Total number of mechanical ventilation days from endotracheal intubation to discharge from intensive care unit |
| One year mortality | Within 1 year of randomisation | Incidence or death during one year of randomisation |
| Health related quality of life | Within 1 year of randomisation | Heath related quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) one year of randomisation |
| Length of intensive care unit and hospital stay | Within 30 days of randomisation | Total cumulative number of days spent in intensive care unit and hospital |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of awake prone positioning | Within 72 hours of randomisation | Proportion of patients in the intervention group completing at least 4 hours per day of awake prone positioning and number of awake prone hours per day |
Countries
Lithuania, United Kingdom
Contacts
Primary ContactTomas Jovaisa, Prof
Outcome results
None listed