Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Prone Positioning on Mortality in Patients With Severe and Persistent Acute Respiratory Distress Syndrome
Brief Summary: We project to test the effect of prone position on mortality in severe ARDS patients (PaO2/FiO2\<150 with FiO2 \> or = 0.6 and positive end-expiratory pressure \> or = 5 cmH2O). Ventilator will be set in accordance with current standards aiming at protecting the lungs from VALI. Patients will be randomized into two arms: prone group in which proning will be realized for at least 16 hours a day and supine group in which patients will stay in a semi-recumbent position. Primary end-point is 28-day mortality of all causes. Secondary end-points are 90-day mortality of all causes and incidence of ventilator-acquired pneumonia. Study sample was calculated to detect ability of proning to reduce mortality from 60 to 45% percent, at one-tailed alpha error of 5% and power of 90% and 230 patients are needed in each arm.


Options:
A: Inclusion Criteria:

* Man or female older than 18 years
* ARDS since less than 12 hours
* PaO2 / FiO2 \< 200 avec une PEEP ≥ 5 (Berlin Moderate or severe)

Exclusion Criteria:

* brain injury with high ICP
* BMT Liver Cirrhosis Child C Pregnancy Burns Morbid obese patients (BMI \> 40) Moribund
B: Inclusion Criteria:

1. Adult patients aged 18 years or more, both gender
2. Receiving endotracheal intubation and mechanical ventilation for less than 36 hours
3. Presenting with a Severe ARDS :

   * Acute onset
   * PaO2/FiO2 ≤ 200 (≤ 26.7 kPa)
   * Bilateral pulmonary infiltrates on frontal chest radiography
   * Capillary wedge pressure \< 18 mm Hg if measured or no evidence for left atrial hypertension
4. During since 12-24 hours
5. AND with severity criteria : PaO2/FiO2 \< 150 mm Hg (\< 20 kPa) under FiO2 ≥ 0.6, PEEP ≥ 5 cm H2O and a tidal volume equal to 6 ml/kg PBW.
6. Written consent from patient's next of kin

Exclusion Criteria:

1. contra-indication to the prone position

   * Intracranial pressure \> 30 mm Hg or cerebral perfusion pressure \< 60 mm Hg
   * Massive haemoptysis needing urgent surgical or radiological treatment
   * Tracheal or thoracic surgery in the last 15 days
   * Facial trauma or surgery in the last 15 days
   * Deep venous thrombosis or pulmonary embolism treated in the last 2 days
   * Cardiac pace maker implantation in the last 2 days
   * Unstable bone dislocations of rachis, femur, rib cage, pelvis
   * Mean systolic arterial pressure less than 70 mm Hg despite vasopressive therapy
   * Pregnancy
   * Bronchopleural fistula treated with a single anterior chest tube (risk of kinking in prone position)
2. Exclusion criteria for respiratory raisons

   * Necessity to use NOi or almitrine
   * Extra body circulation for oxygenation and/or CO2 epuration
3. Exclusion criteria linked to clinical context

   * Pulmonary transplantation
   * Burns ≥ 20% of body surface
   * Chronic respiratory insufficiency under home oxygen therapy or non invasive ventilation
   * Chronic disease supposed to be fatal in less than 1 year
   * Non invasive ventilation for more than 24 hours before enrollment
4. Other exclusion criteria

   * Decision to stop life-supportive therapies before enrollment
   * Enrollment in an other trial testing an intervention and with mortality as primary end point in the last 30 days
   * Prior enrollment in the same study
   * Prone position before enrollment
C: Inclusion Criteria:

* Mechanical ventilation through an endotracheal tube
* Bilateral infiltrates consistent with pulmonary edema
* PaO2/FiO2 \< 300 mmHg
* No clinical evidence of left atrial hypertension. If measured, pulmonary artery occlusion pressure \< 18 mmHg
* Criteria 1, 2 et 3 jointly present for less than 48 hours
* Written informed consent obtained from the patient or surrogate

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Expected duration of mechanical ventilation through an endotracheal tube \< 48 hours
* Participation in other trials within the previous 30 days
* Increased intracranial pressure
* Severe chronic respiratory disease
* Morbid obesity (weight \> 1kg/cm)
* Sickle cell disease
* Bone marrow transplant or chemotherapy-induced neutropenia
* Extended burns (\> 30 % total body surface area)
* Severe chronic liver disease (Child-Pugh score C)
* Pneumothorax
D: Inclusion Criteria:

Adult ICU patients who met all of the following criteria:

* Currently intubated and receiving mechanical ventilation
* Within 72 Hours of a diagnosis of ARDS (moderate and severe) based on the following Berlin definition:
* Within 1 week of a known clinical insult or new or worsening respiratory symptoms
* Bilateral opacities on chest x-ray (CXR) which are not fully explained by effusions, lobar/lung collapse or nodules
* Respiratory failure not fully explained by cardiac failure or fluid overload
* Arterial oxygen pressure (PaO2)/FiO2 \< 200mmHg with PEEP ≥ 5cmH2O

Exclusion Criteria:

* \> 72 hours since diagnosis of ARDS
* \> 10 days of continuous mechanical ventilation
* Barotrauma (pneumothorax, pneumomediastinum, subcutaneous emphysema or any intercostal catheter for the treatment of air leak)
* Significant chest trauma i.e. multiple rib fractures
* Active bronchospasm or a history of significant chronic obstructive pulmonary disease or asthma
* Clinical suspicion for significant restrictive lung disease (history of pulmonary fibrosis or suggestive pulmonary function tests)
* Moderate or severe traumatic brain injury, the presence of an intracranial pressure monitor, or any medical condition associated with a clinical suspicion of raised intracranial pressure
* Unstable cardiovascular status defined as sustained heart rate \< 40 or \> 140 bpm, ventricular tachycardia, or SBP \< 80mmHg
* Pregnancy
* Receiving ECMO
* Receiving high frequency oscillatory ventilation
* Death is deemed imminent and inevitable
* The treating physician believes it is not in the best interest of the patient to be enrolled in the trial
* Consent not obtained or refused by patient's legal surrogate

Answer: B