PRone positioN in Patients With spontanEous ventiLation and Acute Hypoxemic respIratory FailurE

Study Overview
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Brief Summary
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The proposed randomized controlled trial aims at comparing the application of the prone position in spontaneously breathing patients with acute hypoxemic respiratory failure from any cause versus standard treatment on the rate of invasive mechanical ventilation or all-cause of mortality. The secondary endpoints will include time to tracheal intubation and effects of awake proning on the oxygenation parameters, dyspnea sensation, complications, and tolerance. Other endpoints are ventilation free-days at 28 days, duration of invasive ventilation, length of ICU and hospital stay, ICU and hospital mortality, and 28, 60, and 90-day mortality.

Detailed Description
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The investigators intend to recruit acute hypoxemic respiratory failure patients with a respiratory rate of more than 25 breaths per minute, SpO2 < 94% and FiO2 of at least 40% or more by either Venturi facemask, HFNC, or NIV/CPAP and, absence of decompensated respiratory acidosis during two years. Currently, the investigators expect about 35 centers to participate in the trial. Demographic data and clinical characteristics on screened patients, regardless of enrolment criteria match, will be recorded (registry). The investigators will randomize 650 patients admitted to the participating centers' intensive care units and expect each participating center to randomize at least 25 patients who meet all inclusion criteria.

Official Title
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PRone positioN in Patients With spontanEous ventiLation and Acute Hypoxemic respIratory FailurE

Conditions
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Respiratory Failure With Hypoxia, Respiratory Failure Without Hypercapnia

Intervention / Treatment
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* Other: Prone Position


Participation Criteria
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Eligibility Criteria
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Inclusion criteria >18 years Acute respiratory failure from any cause Admitted to a participating ICU Written informed consent Exclusion criteria Presence of any contraindication to prone position (APPENDIX i) The patient meets the criteria for intubation (see item 7.2.3) Participating in other interventional studies with the same primary outcome Receiving comfort care only Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prone position<br>Patients with acute hypoxemic respiratory failure from any cause | Other: Prone Position<br>* The best-fitting and most-tolerated oxygen interface will be used in the prone position--this could be different from patient to patient, and different from what is used in the supine position, and could differ between patients but also institutions (i.e., depending on the availability of masks with or without a reservoir bag and with or without the Venturi system, HFNO, CPAP or NIV). The patient will be placed in the prone position for at least 2 hours, which may be prolonged if the patient is comfortable or interrupted if the patient presents any criteria for prone position discontinuation. After the prone position period, the patient will be rotated to the semi-recumbent supine position for at least 2 hours and a maximum of 4 hours. This 2-hour time frame will depend on nursing availability, need for hygiene, complementary explorations, or diet.<br>|
| No Intervention: Supine position<br>Patients with acute hypoxemic respiratory failure from any cause | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint comprising the rate of tracheal intubation or all-cause of mortality during the first fourteen days of enrolment. |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at day 14 | Effect of prone position on mortality | 14 days | 
| Intubation among survivors at day 24 | Effect of prone position on the rate of intubation | 24 days | 
| Effects on oxygenation defined by the SpO2 | Effects of prone position on oxygenation | 4 hours | 
| Days under the oxygen support device | Days under the oxygen support device (HFNC, NIV, non-rebreather mask, Venturi mask) The VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best). | 28 days | 
| Dyspnea | Effects of prone position on dyspnea, defined according modified Borg dyspnea scale. This is a scale rates the difficulty of breathing. It starts at number 0 where dyspnea is causing no difficulty at all and progresses through to number 10 where dyspnea is maximal. | 4 hours | 
| Time to tracheal intubation | Effects of prone position on timing for tracheal intubation | 14 days | 
| Rate of complications related to prone position | Effects of prone position on adverse effects such Oxygen desaturations (SpO2 <90%) Episodes of hemodynamic instability (BPsys < 90mmHg or BPsys drop > 10mmHg if BPsys < 90 before the maneuver) Need of orotracheal intubation Cardiac arrest Displacement of the non-invasive respiratory support device Removal of central venous line, if documented Displacement of an arterial line, if documented Displacement of a urinary catheter, if documented | 4 hours | 
| Respiratory rate | Effects of prone position of respiratory rate | 4 hours | 
| Duration of invasive mechanical ventilation | Duration of invasive mechanical ventilation in those patients who required intubation | 90 days | 
| Ventilation-free days (VFD) at 28 days from ICU admission, | Ventilation-free days (VFD) at 28 days from ICU admission, defined as the number of days alive and free from IMV during the first 28 days from start of IMV | 28 days | 
| ICU-free days and hospital-free days | ICU-free days and hospital-free days at day 90 | 90 days | 
| Mortality | Mortality at day 28 and day 90 | 28 and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prone position, Acute Respiratory Failure