Status:
RECRUITING
HYPoxaEmic Respiratory Failure and Awake Prone Ventilation
Lead Sponsor:
Vilnius University
Collaborating Sponsors:
Vilnius University Hospital Santaros Klinikos
Conditions:
Respiratory Failure
Hypoxemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 m...
Detailed Description
Effectiveness of prone position in mechanically ventilated patients was investigated extensively. During the Covid-19 pandemic a sudden increase in cases of acute respiratory failure, resulted in rene...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT05990101
Start Date
May 12 2023
End Date
September 1 2028
Last Update
August 14 2023
Active Locations (4)
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1
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania
2
Republican Vilnius University Hospital
Vilnius, Lithuania, 04130
3
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
4
Barking, Havering and Redbridge University Hospitals NHS Trust
London, United Kingdom