Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
Brief Summary: The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.


Options:
A: Inclusion Criteria:

* Must meet the following three criteria within a 24-hour period:

  1. Acute onset of PaO2/FiO2 less than or equal to 300 (adjustments made for altitude where appropriate)
  2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
  3. Requirement for positive pressure ventilation via endotracheal tube
* No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates

Exclusion Criteria:

* Greater than 48 hours since all inclusion criteria are met
* Neuromuscular disease that impairs ability to ventilate without assistance, (e.g., cervical spinal cord injury at level C5 or higher spinal cord injury amyotrophic lateral sclerosis, Guillain-Barré syndrome or myasthenia gravis)
* Pregnant or breast-feeding
* Severe chronic respiratory disease (i.e., chronic hypercapnia \[PaCO2 greater than 45 mmHg\], chronic hypoxemia \[PaO2 less than 55 mmHg on FiO2 = 0.21\], hospitalization within the last 6 months for respiratory failure \[PaCO2 greater than 50 mm Hg and/or PaO2 less than 55 mmHg on 0.21 FiO2\], secondary polycythemia, severe pulmonary hypertension \[mean PAP (pulmonary artery pressure) greater than 40 mmHg\], or ventilator dependency)
* Burns over greater than 40% of total body surface area
* Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
* Allogeneic bone marrow transplant within the 5 years prior to study entry
* Participant, surrogate, or physician is not committed to full support (Exception: a participant will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
* Severe chronic liver disease (Child-Pugh score of 11-15)
* Diffuse alveolar hemorrhage from vasculitis
* Morbid obesity (greater than 1kg/cm body weight.)
* Unwillingness or inability to utilize the ARDS network 6 ml / kg Predicted Body Weight (PBW) ventilation protocol
* Moribund participant and is not expected to survive 24 hours
* No intent to obtain central venous access for monitoring intravascular pressures
* Contraindication to aerosolized albuterol (see Appendix A.8 of the protocol for more information)
* Daily use (prior to study hospitalization) of inhaled beta agonist, corticosteroid, or oral leukotriene modifier
* Unwillingness of primary physician to discontinue inpatient beta agonist use
* Acute myocardial infarction or acute coronary syndrome within 30 days of study entry
* Severe congestive heart failure (see Appendix A5 of the protocol for more information)
* Participation in other experimental medication trial within 30 days of study entry with the exception of the ARDSNet pharmaconutrient nutrition trial (OMEGA)
* Heart rate greater than 85% of maximal predicted heart rate (MHR85) as calculated by MHR85 = 85% x (220-age)
* Currently receiving high frequency ventilation
B: Inclusion Criteria:

* Invasive mechanical ventilation
* Acute respiratory insufficiency (within past 28 days)
* Bilateral infiltrates on frontal chest radiograph
* Hypoxemia, defined as PaO2/FiO2\<=250

Exclusion Criteria:

* Primary cause of respiratory failure is cardiac
* Anticipated duration of mechanical ventilation \< 48 hours
* Inability to wean other experimental ventilation strategies
* Severe chronic respiratory disease
* Neuromuscular disease that will prolong mechanical ventilation
* Conditions where hypercapnia-induced intracranial hypertension should be avoided
* Morbid obesity (\> 1Kg per cm body weight)
* Pregnancy
* Very unlikely to survive and lack of commitment to life support Underlying irreversible condition with 6 month mortality \>= 50%
* Greater than 48 hours elapsed since first eligible
* Current participation in competing trial
* Lack of physician, patient or proxy consent
C: Inclusion Criteria:

Patients with ALI/ARDS according to the International Consensus Conference criteria:

* PaO2/FiO2 ratio \< 300
* Acute onset
* Bilateral infiltrates on chest radiography
* PAOP \< 18 or, in patients without a pulmonary artery catheter, no other evidence of abnormal cardiac function

Exclusion Criteria:

* Patients with esophageal varices
* Patients with esophageal trauma
* Patients with recent esophageal surgery
* Patients with coagulopathy (platelets \< 80k or International Normalized Ratio \[INR\]\> 2 )
* Post transplant patients
* Patients with significant broncho-pleural fistula
D: 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

Answer: D