HYPoxaEmic Respiratory Failure and Awake Prone Ventilation (Hyper-AP)

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Hypoxemia
• Intervention / Treatment: Behavioral: Awake prone position (APP)

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.

• Study Type: Interventional
• Enrollment (Estimated): 262
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomas Jovaisa, Prof; Phone Number: +37062697567; Email: tomas.jovaisa@santa.lt

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • Not yet recruiting
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
    • Contact: Tomas Tamosuitis, Dr; Phone Number: +37068780950; Email: Tomas.Tamosuitis@kaunoklinikos.lt
  • Vilnius, Lithuania
    • Recruiting
    • Vilnius University Hospital Santaros Klinikos
  • Vilnius, Lithuania, 04130
    • Not yet recruiting
    • Republican Vilnius University hospital
    • Contact: Saulius Vosylius, Prof; Email: saulius.vosylius@gmail.com
• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • Barking, Havering and Redbridge University Hospitals NHS Trust
    • Contact: Mandeep K Phull, Dr; Email: mandeep.phull@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APP group; Awake prone position (APP) for 4 or more hours per day in addition to standard care for the first 72 hours from randomisation. After the initial period, use of APP is at discretion of the treating clinician. Awake prone can be discontinued earlier if patients meets pre-specified criteria of sustained improvement.	Behavioral: Awake prone position (APP); Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.
No Intervention: Control group; Standard care excluding APP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of endotracheal intubation	Incidence of endotracheal intubation in both groups	Within 30 days of randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality during intensive care unit stay, in hospital, at day 90 and at 1 year	Within 1 year of randomisation
Duration of mechanical ventilation	Total number of mechanical ventilation days from endotracheal intubation to discharge from intensive care unit	Within 30 days of randomisation
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
One year mortality	Incidence or death during one year of randomisation	Within 1 year of randomisation
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: Vilnius University Hospital Santaros Klinikos
• Investigators: Principal Investigator: Ieva Jovaisiene, Dr, Vilnius University Hospital Santaros Klinikos; Principal Investigator: Mandeep K Phull, Dr, Barking, Havering and Redbridge University Hospitals NHS Trust; Principal Investigator: Tomas Jovaisa, Prof, Vilnius University Hospital Santaros Klinikos

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ARDS; Respiratory failure; Hypoxaemia; Awake prone
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia
• Other Study ID Numbers: 2023/6-1517-981

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No