Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prone-Supine Study II: The Effect of Prone Positioning for Patients Affected by Acute Respiratory Distress Syndrome
Brief Summary: The purpose of this study is to determine whether prone positioning is effective in improving survival in patients affected by acute respiratory distress syndrome (ARDS).


Options:
A: Inclusion Criteria:

* Age 18-75 years
* Body weight \> 40 kg
* Endotracheal intubation and mechanical ventilation
* Diagnosis of ARDS established within preceding 72 h
* Severe oxygenation disturbances: PaO2/FiO2 \<150 mm Hg sustained for 12 h, despite being ventilated with PEEP ≥8 cm H2O

Exclusion Criteria:

* Active air leak or recent severe air leak (severe air leak: \> 1 chest tube per hemithorax with persistent gas leak for \> 72 h)
* Severe hemodynamic instability (i.e., systolic arterial pressure \< 90 mm Hg despite volume loading and norepinephrine infusion at ≥ 0.5 μg/kg/min)
* Significant heart disease (i.e., ejection fraction \<40 %, and/or history of pulmonary edema, and/or active coronary ischemia or myocardial infarction)
* Significant chronic obstructive pulmonary disease (COPD) or asthma {i.e., previous admissions for COPD/asthma, chronic corticosteroid therapy for COPD/asthma, and documented chronic CO2 retention leading to a baseline PaCO2 of \> 50 mm Hg (for COPD)}
* Uncontrollable intracranial hypertension (i.e., intracranial pressure \>20 mm Hg despite deep sedation, analgesia, hyperosmolar therapy, and minute ventilation titrated to PaCO2 = 35 mm Hg)
* Chronic Interstitial Lung Disease associated with bilateral pulmonary infiltrates
* Lung biopsy or resection on current admission
* Immunosuppression caused by

  * neutropenia \[i.e., polymorphonuclear leukocyte count \< 1,000/μL (1 x 1012/L)\] after chemotherapy or bone marrow transplantation for hematologic cancers
  * corticosteroid or cytotoxic therapy for a nonmalignant disease
  * the acquired immunodeficiency syndrome
* Inability to wean from prone positioning or inhaled nitric oxide
* Pregnancy or morbid obesity (body mass index \>40 kg/m2)
* Enrollment in another interventional study
* Crossover from the CMV-group to the HFO-TGI-group at \> 72 h after the onset of the severe oxygenation disturbances
B: Inclusion Criteria:

* Early Acute Respiratory Distress Syndrome
* PaO2/FiO2 \< 150 mm Hg at PEEP ≥ 8 cm H2O
* Age 18-75 years
* Body weight \> 40 kg

Exclusion Criteria:

* More than 1 chest tube/hemithorax with persistent airleak for \> 72 h)
* Systolic pressure \< 90 mm Hg with fluids/norepinephrine at ≥ 0.5 μg/kg/min
* Heart disease (defined in Detailed Description)
* Chronic obstructive pulmonary disease (defined in Detailed Description)
* Intracranial abnormalities (any cause of intracranial pressure \> 20 mm Hg)
* Chronic interstitial lung disease
* Lung biopsy or resection on current admission
* Previous lung or bone marrow transplant or immunosuppression
* Pregnancy or morbid obesity
* Inability to wean from prone positioning or inhaled nitric oxide
* Enrollment in another interventional study
C: 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
D: Inclusion Criteria:

* Patients receiving mechanical ventilation will be enrolled if they meet criteria for acute respiratory distress syndrome, with the PaO2/FiO2 ratio criterion modified as follows:

  * PaO2/FiO2 ratio ≤ 200 with 5 ≤ PEEP ≤ 10 cmH2O

Exclusion Criteria:

* Age \< 16 years.
* \> 72 hours since all inclusion criteria are met.
* Lung transplant, liver transplant or bone marrow transplant.
* Clinical or instrumental evidence of cerebral edema or elevated endocranial pressure.
* Conditions which are thought to contraindicate the use of prone positioning (i.e., not-stabilized bone fracture, column fracture, pelvis fracture, multiple rib fracture with chest-wall instability, severe haemodynamic instability).

Answer: D