NCT05990101

HYPoxaEmic Respiratory Failure and Awake Prone Ventilation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 262 (estimated)
• Sponsor: Vilnius University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Failure
• Hypoxemia

Interventions

Type	Name	Description
BEHAVIORAL	Awake prone position (APP)	Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.

Timeline

• Start date: 2023-05-12
• Primary completion: 2026-08-01
• Completion: 2028-09-01
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

4 sites across 2 countries: Lithuania, United Kingdom