HYPoxaEmic Respiratory Failure and Awake Prone Ventilation
Recruiting now · Not applicable
Conditions studied: Respiratory Failure, Hypoxemia
In brief
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.
Key facts
- Study ID
- NCT05990101
- Run by
- Vilnius University
- People needed
- 262
- Starts
- 2023-05-12
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2023-08-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Vilnius University Hospital Santaros Klinikos — Vilnius, Lithuania (enrolling)
- Hospital of Lithuanian University of Health Sciences Kaunas Clinics — Kaunas, Lithuania
- Republican Vilnius University Hospital — Vilnius, Lithuania
- Barking, Havering and Redbridge University Hospitals NHS Trust — London, United Kingdom
Full record on ClinicalTrials.gov
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