Using awake prone positioning to improve respiratory failure treatment

HYPoxaEmic Respiratory Failure and Awake Prone Ventilation

This study is testing if having patients with breathing problems lie on their stomach while awake can help them breathe better and reduce the need for a breathing tube.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 262 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vilnius University (Academic / other)
• Locations: 4 sites (Kaunas and 3 other locations)
• Trial ID: NCT05990101 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adult patients admitted to intensive care units for acute hypoxemic respiratory failure.

Not a fit: Patients who are unconscious, unable to cooperate, or have immediate indications for intubation will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the need for invasive mechanical ventilation in patients with respiratory failure.

How similar studies have performed: While there have been numerous studies on prone positioning in mechanically ventilated patients, this trial is novel as it focuses on spontaneously breathing patients with acute lung injury unrelated to Covid-19.

Eligibility criteria

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 this trial is running

Kaunas and 3 other locations

• Hospital of Lithuanian University of Health Sciences Kaunas Clinics — Kaunas, Lithuania (Not_yet_recruiting)
• Republican Vilnius University Hospital — Vilnius, Lithuania (Not_yet_recruiting)
• Vilnius University Hospital Santaros Klinikos — Vilnius, Lithuania (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

Conditions Respiratory Failure; Hypoxemia; Awake prone; Respiratory failure; ARDS; Hypoxaemia