Using awake prone positioning to improve respiratory failure treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective multi-centre randomised controlled trial aims to evaluate whether adding awake prone positioning to standard oxygen therapy and non-invasive ventilation can decrease the need for endotracheal intubation in patients with acute hypoxemic respiratory failure. The study is motivated by the renewed interest in prone positioning during the Covid-19 pandemic, although it seeks to address gaps in evidence for non-Covid-19 related acute respiratory distress. By comparing standard care with the addition of awake prone positioning, the trial will provide insights into its effectiveness in a broader patient population. The study will involve adult patients admitted to intensive or intermediate care units for acute respiratory failure, ensuring a robust analysis of the intervention's impact.

Why it matters

Who can join: the full rules

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

Where it's running

• Vilnius University Hospital Santaros Klinikos
  Vilnius, Lithuania Recruiting
• Hospital of Lithuanian University of Health Sciences Kaunas Clinics
  Kaunas, Lithuania Not yet recruiting
• Republican Vilnius University Hospital
  Vilnius, Lithuania Not yet recruiting
• Barking, Havering and Redbridge University Hospitals NHS Trust
  London, United Kingdom Not yet recruiting

Study contacts

• Principal investigator: Ieva Jovaisiene, Dr — Vilnius University Hospital Santaros Klinikos
• Study coordinator: Tomas Jovaisa, Prof
• Email: tomas.jovaisa@santa.lt
• Phone: +37062697567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.