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HYPoxaEmic Respiratory Failure and Awake Prone Ventilation

RecruitingNAAges 18 Years - anyAllVilnius University
NCT05990101 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Awake prone position (APP)
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Where

4 sites
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania
Republican Vilnius University Hospital
Vilnius, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
Barking, Havering and Redbridge University Hospitals NHS Trust
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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