RecruitingNot ApplicableNCT05990101
HYPoxaEmic Respiratory Failure and Awake Prone Ventilation
Sponsor
Vilnius University
Enrollment
262 participants
Start Date
May 12, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria8
- 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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Interventions
BEHAVIORALAwake prone position (APP)
Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.
Locations(4)
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NCT05990101
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