Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective, Randomized, Multi-Center Trial of Initial Trophic Enteral Feeding Followed by Advancement to Full-Calorie Enteral Feeding vs. Early Advancement to Full-Calorie Enteral Feeding in Patients With Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS) and Prospective, Randomized, Blinded, Placebo-Controlled, Multi-Center Trial of Omega-3 Fatty Acid, Gamma-Linolenic Acid, and Anti-Oxidant Supplementation in the Management of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS)
Brief Summary: Acute respiratory distress syndrome (ARDS) and acute lung injury (ALI) are medical conditions that occur when there is severe inflammation and increased fluids in both lungs, making it difficult for the lungs to function properly. Hospital treatment for a person with ALI/ARDS often includes the use of a breathing machine, or ventilator, until the person is able to breathe without assistance. Initiating proper nutrition through a feeding tube early in a person's hospital stay may help to improve recovery, but the optimal timing, composition, and amount of feeding treatments are unknown. This study will evaluate whether early or delayed full-calorie feeding through a feeding tube is more effective in reducing recovery time and increasing survival rates in people with ALI/ARDS. The study will also determine whether supplementing the feedings with omega-3 fatty acids and antioxidants benefits people with ALI/ARDS.


Options:
A: Inclusion Criteria:

* Must meet the following three criteria within a 24-hour period of study entry: 1) PaO2/FiO2 less than or equal to 300 (if altitude is more than 1000 meters, then PaO2/FiO2 less than or equal to 300 x \[barometric pressure/760\]), 2) bilateral infiltrates (patchy, diffuse, homogeneous, or asymmetric) consistent with pulmonary edema on frontal chest radiograph, and 3) requirement for positive pressure ventilation via endotracheal tube
* No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates
* Intention of primary medical team to enterally feed the patient
* Undergoes enteral feeding within 48 hours of meeting other inclusion criteria

Exclusion Criteria:

* Neuromuscular disease that impairs ability to breathe without assistance, such as cervical spinal cord injury at level C5 or higher, amyotrophic lateral sclerosis, Guillain-Barré syndrome, or myasthenia gravis
* Pregnant or breastfeeding
* Severe chronic respiratory disease (more information about this criterion can be found in the protocol)
* Burns on greater than 40% total body surface area
* Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% (more information about this criterion can be found in the protocol)
* Allogeneic bone marrow transplant in the 5 years before study entry
* Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
* Severe long-term liver disease (Child-Pugh score of 11 to 15)
* Diffuse alveolar hemorrhage from vasculitis
* Morbid obesity, defined as 1 kg/cm body weight
* Unwilling or unable to use the ARDS network 6 mL/kg PBW ventilation protocol
* Moribund patient not expected to survive 24 hours after study entry
* No intent to obtain central venous access for monitoring intravascular pressures
* More than 72 hours since mechanical ventilation initiated
* Refractory shock (more information about this criterion can be found in the protocol)
* Unable to obtain enteral access
* Presence of partial or complete mechanical bowel obstruction
* Presence of ischemia or infarction
* Current total parenteral nutrition (TPN) use or intent to use TPN within 7 days of study entry
* Severe malnutrition with body mass index less than 18.5 or loss of more than 30% total body weight in the 6 months before study entry
* Laparotomy expected within 7 days of study entry
* Unable to raise head of bed 30 to 45 degrees
* Short-bowel syndrome or absence of gastrointestinal tract
* Presence of high-output (greater than 500 cc/day) enterocutaneous fistula
* International normalized ratio greater than 5.0, platelet count less than 30,000/mm3, or history of bleeding disorder
* Intracranial hemorrhage in the 1 month before study entry
* Allergy to enteral formula
* Requirement for, or physician insistence on, enteral formula supplemented with omega-3 fatty acids (e.g., Oxepa®, Impact®) or treatment with omega-3 fatty acid, gamma-linolenic acid (GLA), or antioxidant supplementation
B: Inclusion Criteria:

* Must meet the following three criteria at study entry within a 24-hour period: 1) PaO2/FiO2 less than or equal to 300 (if altitude is more than 1000 meters, then PaO2/FiO2 less than or equal to 300 x \[barometric pressure/760\]), 2) bilateral infiltrates (patchy, diffuse, homogeneous, or asymmetric) consistent with pulmonary edema on frontal chest radiograph, and 3) requirement for positive pressure ventilation via endotracheal tube
* No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates
* Intention of primary medical team to enterally feed the patient
* Undergoes enteral feeding within 48 hours of meeting inclusion criteria

Exclusion Criteria:

* Neuromuscular disease that impairs ability to breath without assistance, such as cervical spinal cord injury at level C5 or higher, amyotrophic lateral sclerosis, Guillain-Barré syndrome, or myasthenia gravis
* Pregnant or breastfeeding
* Severe chronic respiratory disease. More information about this criterion can be found in the protocol.
* Burns on greater than 40% total body surface area
* Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%. More information about this criterion can be found in the protocol.
* Allogeneic bone marrow transplant within the 5 years before study entry
* Patient, surrogate, or physician not committed to full support (exception: a patient 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 to 15)
* Diffuse alveolar hemorrhage from vasculitis
* Morbid obesity, defined as 1 kg/cm body weight
* Unwilling or unable to use the ARDS network 6 mL/kg PBW ventilation protocol
* Moribund patient not expected to survive 24 hours
* No intent to obtain central venous access for monitoring intravascular pressures
* More than 72 hours since mechanical ventilation initiated
* Refractory shock. More information about this criterion can be found in the protocol.
* Unable to obtain enteral access
* Presence of partial or complete mechanical bowel obstruction
* Presence of ischemia or infarction
* Current total parenteral nutrition (TPN) use or intent to use TPN within 7 days of study entry
* Severe malnutrition with body mass index less than 18.5 or loss of more than 30% total body weight in the 6 months before study entry
* Laparotomy expected within 7 days of study entry
* Unable to raise head of bed 30 to 45 degrees
* Short-bowel syndrome or absence of gastrointestinal tract
* Presence of high-output (greater than 500 cc/day) enterocutaneous fistula
* International normalized ratio greater than 5.0, platelet count less than 30,000/mm3, or history of bleeding disorder
* Intracranial hemorrhage within the 1 month before study entry
* Allergy to enteral formula, omega-3 fatty acids, GLA, vitamin E, vitamin C, beta-carotene, taurine, or L-carnitine
* Requirement for, or physician insistence on, enteral formula supplemented with omega-3 fatty acids (ex: Oxepa®, Impact®) or providing omega-3 fatty acid, GLA, or antioxidant supplementation
C: Inclusion Criteria:

* Severe stroke occurred in 7 days.
* GCS ≤12 or NIHSS≥11.
* Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
* Plan to receive enteral feeding for at least 7 days.
* Informed consent.

Exclusion Criteria:

* Gastrointestinal diseases before stroke, such as gastrointestinal resection, malabsorption,and irritable bowel syndrome.
* Brain death.
* Complicated with the disease which only have life expectancy \< 6 months in over 50% patients.
* After cardiac arrest.
* Received parenteral nutrition support.
* Pregnant woman.
* Concurrent severe hepatic or renal dysfunction。
* Unstable hemodynamics.
D: Inclusion Criteria:

* Intubated and receiving mechanical ventilation
* About to commence enteral nutrition or enteral nutrition commenced within the previous12 hours
* Expected to be receiving enteral nutrition in ICU until at least the day after tomorrow

Exclusion Criteria:

* Any Enteral Nutrition (EN) or Parenteral Nutrition (PN) received for \>12 hours in this ICU admission
* Treating clinician considers the EN goal rate (i.e.1ml/kg of ideal body weight per hour) to be clinically contraindicated e.g. requirement for fluid restriction
* Requirement for specific nutritional therapy as determined by the treating doctor or dietitian i.e. TARGET protocol EN not considered to be in the best interest of the patient
* Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment
* The patient has an underlying disease that makes survival to 90 days unlikely
* ≥ 15% burns
* Previously enrolled in this study

Answer: B