Clinical trial NCT05990101: HYPoxaEmic Respiratory Failure and Awake Prone Ventilation
Official title: HYPoxaEmic Respiratory Failure and Awake Prone Ventilation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Failure
Hypoxemia
Keywords: Awake prone
Respiratory failure
ARDS
Hypoxaemia
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Vilnius University Hospital Santaros Klinikos
First posted: 2023-08-14
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be allocated to the awake prone or standard care groups on a 1:1 ratio.
Primary purpose: TREATMENT

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.

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 renewed interest and numerous studies on applying this concept in spontaneously breathing patients and using this in conjunction with less invasive respiratory support. However, evidence form the Covid-19 trials may not be directly extrapolated to other acute respiratory distress causes (for example bacterial pneumonia) as pathology of lung injury is distinctly different. Even though first reports of awake prone positioning were published nearly 30 years ago, but to date there are no prospective randomised trials in adult population treated for acute lung injury unrelated to Covid-19. Existing publications range from case reports (lung transplantation and drowning cases) to small feasibility trials involving 15-20 patients and also neonatal and paediatric populations. Considering that patients with acute lung injury constitute a significant proportion of routine intensive care unit population, results of this study would be highly relevant for the daily practice in intensive care medicine.We are aiming to conduct a prospective multi-centre randomised controlled trial comparing standard care alone with awake prone positioning and standard care in spontaneously breathing patients admitted to Intensive or Intermediate Care Units for acute non-Covid-19 hypoxemic respiratory failure.

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

Primary outcomes:
measure: Rate of endotracheal intubation
timeFrame: Within 30 days of randomisation
Secondary outcomes:
measure: Mortality
timeFrame: Within 1 year of randomisation
measure: Duration of mechanical ventilation
timeFrame: Within 30 days of randomisation
measure: Length of intensive care unit and hospital stay
timeFrame: Within 30 days of randomisation
measure: One year mortality
timeFrame: Within 1 year of randomisation
measure: Health related quality of life
timeFrame: Within 1 year of randomisation
Other outcomes:
measure: Tolerance of awake prone positioning
timeFrame: Within 72 hours of randomisation
Locations:
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics
city: Vilnius
country: Lithuania
facility: Republican Vilnius University Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: London
country: United Kingdom
facility: Barking, Havering and Redbridge University Hospitals NHS Trust
Study officials:
affiliation: Vilnius University Hospital Santaros Klinikos
name: Ieva Jovaisiene, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Barking, Havering and Redbridge University Hospitals NHS Trust
name: Mandeep K Phull, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Vilnius University Hospital Santaros Klinikos
name: Tomas Jovaisa, Prof
role: PRINCIPAL_INVESTIGATOR
References: