HYPoxaEmic Respiratory Failure and Awake Prone Ventilation

NCT ID: NCT05990101

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-12
• Study Completion Date: 2028-09-01

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.

Conditions

Respiratory Failure; Hypoxemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Awake prone position (APP)

Intervention Type: BEHAVIORAL

Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.

Control group

Standard care excluding APP

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Awake prone position (APP)

Awake prone position for 4 or more hours per day for the first 72 hours following randomisation.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role: collaborator

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ieva Jovaisiene, Dr

Role: PRINCIPAL_INVESTIGATOR

Vilnius University Hospital Santaros Klinikos

Mandeep K Phull, Dr

Role: PRINCIPAL_INVESTIGATOR

Barking, Havering and Redbridge University Hospitals NHS Trust

Tomas Jovaisa, Prof

Role: PRINCIPAL_INVESTIGATOR

Vilnius University Hospital Santaros Klinikos

Locations

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, , Lithuania

Site Status: NOT_YET_RECRUITING

Republican Vilnius University Hospital

Vilnius, , Lithuania

Site Status: NOT_YET_RECRUITING

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Site Status: RECRUITING

Barking, Havering and Redbridge University Hospitals NHS Trust

London, , United Kingdom

Site Status: NOT_YET_RECRUITING

Countries

Lithuania; United Kingdom

Central Contacts

Tomas Jovaisa, Prof

Role: CONTACT

tomas.jovaisa@santa.lt

+37062697567

Facility Contacts

Tomas Tamosuitis, Dr

Role: primary

Tomas.Tamosuitis@kaunoklinikos.lt

+37068780950

Saulius Vosylius, Prof

Role: primary

saulius.vosylius@gmail.com

Mandeep K Phull, Dr

Role: primary

mandeep.phull@nhs.net

Other Identifiers

2023/6-1517-981

Identifier Type: -

Identifier Source: org_study_id