RecruitingNot ApplicableNCT05990101

HYPoxaEmic Respiratory Failure and Awake Prone Ventilation

Sponsor

Vilnius University

Enrollment

262 participants

Start Date

May 12, 2023

Study Type

INTERVENTIONAL

Conditions

Respiratory Failure Hypoxemia

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