Please select the eligibility criteria that correspond to the clinical trial below.
Title: ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial
Brief Summary: Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator. The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of setting the ventilator.


Options:
A: Inclusion Criteria:

* Acute onset of ARDS as defined by the Berlin Consensus Conference definitions:

  1. Hypoxemic respiratory failure with PaO2 / FIO2 ratio \< 200 mmHg
  2. b) Bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days
  3. Respiratory failure not fully explained by cardiac failure or fluid overload
  4. Intubation on controlled ventilation and receiving PEEP ≥ 5 cm H2O
* Age 16 years or older
* Duration of ARDS 36 hours or less from meeting final Berlin criterion.

Exclusion Criteria:

* Received mechanical ventilation more than 96 hours
* Recently treated or bleeding varices, esophageal stricture, hematemesis, esophageal trauma, recent esophageal surgery or other contraindication for nasogastric tube placement
* Severe coagulopathy (platelet count \< 5000/microliter or INR \> 4)
* History of lung transplantation
* Elevated intracranial pressure or conditions where hypercapnia-induced elevations in intracranial pressure should be avoided
* Evidence of active air leak from the lung
* not committed to full support
* Participation in other intervention trials for ARDS or for sepsis within the past 30 days.
* Neuromuscular disease that impairs ability to ventilate spontaneously
* Severe chronic liver disease, defined as Child-Pugh Score of ≥12
* Treating clinician refusal, or unwillingness to commit to controlled ventilation for at least 24 hours
* Inability to get informed consent from the patient or surrogate.
* Use of rescue therapies for prior to enrollment (e.g. nitric oxide, ECMO, prone positioning, high frequency oscillation). This does not exclude cases where these therapies were used as the initial mode of ventilation
B: 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
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:

* Intubated and mechanically ventilated
* Diagnosis of ARDS using American-European consensus criteria
* Enrollment in study \< 48 hours since diagnosis of ARDS
* For 12-36 hrs. (ideally 12-24 hrs) after diagnosis of ARDS, patient must be ventilated as follows: Volume A/C, Tidal volume of 4-8 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, PEEP/FIO2 adjustments using ARDSnet table, Ventilator rate to keep PaCO2 = 35-60 mmHg
* During the 12-36 hour(ideally 12-24 hr) period, PaO2/FIO2 must remain \< 200 mm Hg for an ABG obtained 30 minutes after placement on the following specific ventilator settings: Volume A/C, Tidal volume = 6 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, Inspiratory time ≤ 1 second, PEEP ≥ 10 cmH2O, FIO2 ≥ 0.5, Ventilator rate to keep PaCO2 = 35-60 mmHg
* No lung recruitment maneuvers or adjunct therapy.
* Total time on mechanical ventilation \< 96 hrs. at time of randomization.

Exclusion Criteria:

* Age \< 18 years or \> 80 years
* Weight \< 35 kg PBW
* Body mass index \> 60
* Intubated 2° to acute exacerbation of a chronic pulmonary disease
* Acute brain injury (ICP \> 18 mmHg)
* Immunosuppression 2° to chemo- or radiation therapy
* Severe cardiac disease(one of the following): New York Heart Association Class 3 or 4, acute coronary syndrome or persistent ventricular tachyarrhythmias
* Positive laboratory pregnancy test
* Sickle cell disease
* Neuromuscular disease
* High risk of mortality within 3 months from cause other than ARDS, e.g. cancer
* More than 2 organ failures (not including pulmonary system)
* Documented lung barotrauma, i.e. chest tube placement other than for fluid drainage
* Persistent hemodynamic instability or intractable shock
* Penetrating chest trauma
* Enrollment in another interventional study

Answer: D