Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Oscillation for ARDS Treated Early (OSCILLATE) Trial Pilot Study
Brief Summary: Acute respiratory distress syndrome (ARDS) is a common and catastrophic complication of critical illness related to burns, motor vehicle accidents, or overwhelming infection. ARDS kills 40-70% of affected patients. Patients with ARDS require life support in the form of a ventilator to breathe for them while their lungs heal. Ironically, ventilators can cause further damage to the lungs. We are conducting a study comparing 2 methods to protect the lungs from further damage. One method uses standard mechanical ventilators and the other uses a new type of ventilator, called a high frequency oscillator. We propose to test whether this high frequency oscillation will reduce the relative risk of dying from ARDS. 72 patients from 12 intensive care units in Canada and Saudi Arabia will participate in this preliminary study to test the feasibility of our study methods. If feasible, we plan to move on and conduct a large multinational study to definitively answer this question.


Options:
A: 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).
B: Inclusion Criteria:

* Residing in the ICU
* Receiving mechanical ventilation
* Meets criteria for the diagnosis of ALI/ARDS, as defined by the American-European Consensus Conference

Exclusion Criteria:

* Received diagnosis of ALI/ARDS more than 96 hours prior to study entry
* Received more than five days of mechanical ventilation during the present hospitalization prior to study entry
* Pre-existing ALI/ARDS for more than 24 hours when transferred to the study ICU
* Pre-existing illness with a life expectancy of less than six months
* Any limitations in ICU care at study entry (e.g., no vasopressor)
* Previous lung resection
* Inability to speak or understand English
* No fixed address
C: Inclusion Criteria:

* Patients of either sex, 16 years and above;
* Acute onset of respiratory failure, with fewer than 2 weeks of new pulmonary symptoms;
* Endotracheal intubation or tracheostomy;
* Hypoxaemia - defined as a PaO2/FiO2 ≤ 200 mm Hg;
* Bilateral alveolar consolidation (airspace disease) seen on frontal chest radiograph

Exclusion Criteria:

* Remaining duration of mechanical ventilation \< 48 hours, as judged by the attending physician;
* Primary cause of acute respiratory failure judged by attending physician to be cardiac in origin;
* Lack of commitment to ongoing life support;
* Weight \< 35 kg;
* Severe chronic respiratory disease
* Morbid obesity - defined as \> 1 kg / cm body height;
* Neurological conditions with risk of intracranial hypertension (hypercapnia should be avoided);
* Neuromuscular disease that will result in prolonged need for mechanical ventilation;
* Previous enrolment in this trial;
* All inclusion criteria present for \> 72 hours;
* On HFO at the time of screening.
D: 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

Answer: C