NCT05990101 HYPoxaEmic Respiratory Failure and Awake Prone Ventilation
| NCT ID | NCT05990101 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vilnius University |
| Condition | Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 262 participants |
| Start Date | 2023-05-12 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 262 participants in total. It began in 2023-05-12 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Ieva Jovaisiene, Dr
PRINCIPAL INVESTIGATOR
Vilnius University Hospital Santaros Klinikos
Frequently Asked Questions
Who can join the NCT05990101 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05990101 currently recruiting?
Yes, NCT05990101 is actively recruiting participants. Contact the research team at tomas.jovaisa@santa.lt for enrollment information.
Where is the NCT05990101 trial being conducted?
This trial is being conducted at Kaunas, Lithuania, Vilnius, Lithuania, Vilnius, Lithuania, London, United Kingdom.
Who is sponsoring the NCT05990101 clinical trial?
NCT05990101 is sponsored by Vilnius University. The principal investigator is Ieva Jovaisiene, Dr at Vilnius University Hospital Santaros Klinikos. The trial plans to enroll 262 participants.