Respiratory FailureHyper-APNCT05990101
HYPoxaEmic Respiratory Failure and Awake Prone Ventilation
A study testing Awake prone position (APP) in people with Respiratory Failure and Hypoxemia, run by Vilnius University at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Hypoxemia
- What is being tested?
- Awake prone position (APP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 12 May 2023to 1 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Lithuania3 sites, 3 recruiting
- Not yet recruiting
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas
Tomas Tamosuitis, Dr, +37068780950, Tomas.Tamosuitis@kaunoklinikos.lt
- Not yet recruiting
Republican Vilnius University Hospital
Vilnius, 04130
Saulius Vosylius, Prof, saulius.vosylius@gmail.com
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Barking, Havering and Redbridge University Hospitals NHS Trust
London
Mandeep K Phull, Dr, mandeep.phull@nhs.net
About this study
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.
Read the 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
- Being tested
- Awake prone position (APP)
- Keywords
- Awake prone, Respiratory failure, ARDS, Hypoxaemia
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awake prone position (APP)Behavioural
Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.
| Study group | Role | What they receive |
|---|---|---|
| APP group | Experimental | 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. Receives: Behavioral: Awake prone position (APP) |
| Control group | No intervention | Standard care excluding APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of endotracheal intubation
Incidence of endotracheal intubation in both groups
Measured: Within 30 days of randomisation
Secondary outcomes (5)
Mortality
Mortality during intensive care unit stay, in hospital, at day 90 and at 1 year
Measured: Within 1 year of randomisation
Duration of mechanical ventilation
Total number of mechanical ventilation days from endotracheal intubation to discharge from intensive care unit
Measured: 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
Measured: Within 30 days of randomisation
One year mortality
Incidence or death during one year of randomisation
Measured: 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
Measured: Within 1 year of randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 May 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated to the awake prone or standard care groups on a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Vilnius University Hospital Santaros Klinikos
- Responsible party
- Sponsor
- Investigators
- Ieva Jovaisiene, Dr, Principal investigator, Vilnius University Hospital Santaros KlinikosMandeep K Phull, Dr, Principal investigator, Barking, Havering and Redbridge University Hospitals NHS TrustTomas Jovaisa, Prof, Principal investigator, Vilnius University Hospital Santaros Klinikos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990101
- Sponsor's protocol ID
- 2023/6-1517-981
- Acronym
- Hyper-AP
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jovaisa T, Januskeviciute E, Grinkeviciute G, Montvilaite I, Krauklyte J, Kalimavicius A, Judickas S, Lisauskiene I, Jovaisiene I. Hypoxaemic respiratory failure and awake prone ventilation (HYPER-AP) - Protocol for randomized, controlled clinical trial. Contemp Clin Trials. 2024 Oct;145:107614. doi: 10.1016/j.cct.2024.107614. Epub 2024 Jun 28.
PubMed 38945293