Randomization will happen after initial stabilization phase which may last up to 24 hours
till when patient may or may not have an enteric access. If enteral access is gained and
patient is screened in for the study using inclusion and exclusion criteria, a consent shall
be obtained for enrollment. The tube may be continued to be used if randomized in group A. If
patient is randomized to group B, a postpyloric placement will be achieved.
Randomization using computer software and a unique identification number will be assigned to
every intubated patients who may need mechanical ventilation or tube feed for more than 48
hours.
Randomization will be considered incomplete and the case will be excluded if the process of
assigning group, confirmation of placement of appropriate group specific tube and nutrition
is not initiated within 24 hours.
If patient is randomized into group A, a bedside RN or the intensivist will place a Salem
Sump gastric tube. A nutrition consult for tube feed will be obtained. Confirmation of
gastric placement and not a postpyloric placement will be based on the length of the
orogastric/nasogastric tube and a standard chest radiograph obtained routinely after
intubation. The NG or OG tube should not be more than 65 cm in most cases to prevent it from
migrating into the postpyloric location. A standard enteral tube feed formula will be
initiated. Blood sugars checked via basic metabolic (at least daily) panel and point-of-care
glucose tests (at least every 6 hours) will be obtained. Data collection and Salem Sump
placement will be confirmed by the studying team and will not be known to the RD prescribing
the nutrition.
If a patient is randomized into group B, a trained RN or RD will place the small-bore feeding
feeding tube in the postpyloric position. The effort will be to assure jejunal placement, but
postpyloric placement should be sufficient. If for some reason, the small-bore tube cannot be
passed beyond pylorus, then sufficient length will be left in IRB the stomach and the case
will be noted to have not had the postpyloric placement.
A per protocol analysis and an intention to treat analysis will be carried in the end to take
into consideration cases when placement of tube in certain location could not be achieved.
If a feeding tube becomes occluded, it will be replaced with a new tube within 12 hours. If
the patient had a postpyloric tube and the new tube cannot be positioned in the postpyloric
location, the patient's involvement in the study will be halted (no further data collection).
A standard enteral tube feed formula will be initiated. Blood sugars checked via basic
metabolic (at least daily) panel and point-of-care glucose tests (at least every 6 hours)
will be obtained.