HYPoxaEmic Respiratory Failure and Awake Prone Ventilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVilnius University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Awake prone position (APP)
BehavioralAwake prone position for 4 or more hours per day for the first 72 hours following randomisation.
Treatment groups
262 Participants
are divided into 2 treatment groupsGroup A: APP groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rate of endotracheal intubation
Incidence of endotracheal intubation in both groups
Time frame
Within 30 days of randomisationSecondary outcomes
1
Mortality
Mortality during intensive care unit stay, in hospital, at day 90 and at 1 year
Time frame
Within 1 year of randomisation2
Duration of mechanical ventilation
Total number of mechanical ventilation days from endotracheal intubation to discharge from intensive care unit
Time frame
Within 30 days of randomisation3
Length of intensive care unit and hospital stay
Total cumulative number of days spent in intensive care unit and hospital
Time frame
Within 30 days of randomisation4
One year mortality
Incidence or death during one year of randomisation
Time frame
Within 1 year of randomisationOther outcomes
1
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
Time frame
Within 72 hours of randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vilnius University
Lead sponsor
Vilnius University Hospital Santaros Klinikos
Collaborator
Source ClinicalTrials.gov