HYPoxaEmic Respiratory Failure and Awake Prone Ventilation

Respiratory Failure Clinical Trial

— Hyper-AP  

Official title:

HYPoxaEmic Respiratory Failure and Awake Prone Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990101
• Other study ID #: 2023/6-1517-981
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: September 1, 2028

Study information

• Verified date: July 2023
• Source: Vilnius University
• Contact: Tomas Jovaisa, Prof
• Phone: +37062697567
• Email: tomas.jovaisa[@]santa.lt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: September 1, 2028
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemia
• Hypoxia
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Behavioral:
• Awake prone position (APP)
Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.

Locations

Country	Name	City	State
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics	Kaunas
Lithuania	Republican Vilnius University Hospital	Vilnius
Lithuania	Vilnius University Hospital Santaros Klinikos	Vilnius
United Kingdom	Barking, Havering and Redbridge University Hospitals NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University	Vilnius University Hospital Santaros Klinikos

Countries where clinical trial is conducted

Lithuania,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tolerance of awake prone positioning	Proportion of patients in the intervention group completing at least 4 hours per day of awake prone positioning and number of awake prone hours per day	Within 72 hours of randomisation
Primary	Rate of endotracheal intubation	Incidence of endotracheal intubation in both groups	Within 30 days of randomisation
Secondary	Mortality	Mortality during intensive care unit stay, in hospital, at day 90 and at 1 year	Within 1 year of randomisation
Secondary	Duration of mechanical ventilation	Total number of mechanical ventilation days from endotracheal intubation to discharge from intensive care unit	Within 30 days of randomisation
Secondary	Length of intensive care unit and hospital stay	Total cumulative number of days spent in intensive care unit and hospital	Within 30 days of randomisation
Secondary	One year mortality	Incidence or death during one year of randomisation	Within 1 year of randomisation
Secondary	Health related quality of life	Heath related quality of life assessed by Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) one year of randomisation	Within 1 year of randomisation