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:

* 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:

* 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.
C: 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).
D: 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

Answer: B