Specific Aims: Aim 1: Evaluate the feasibility of intermittent feeding in intensive care unit patients who are mechanically ventilated. Aim 2: Evaluate the safety and patient tolerance of intermittent feeding in intensive care unit patients who are mechanically ventilated. Aim 3: Determine efficacy of intermittent feeding in provision of required nutrition in mechanically ventilated intensive care unit patients. Aim 4: Determine association of intermittent enteral feeding with glycemic control in mechanically ventilated intensive care unit patients.
With the advent of the feeding pump, default enteral nutrition schedules in many medical intensive care units has shifted from intermittent or bolus feeding to continuous feeds. Clinical studies suggest that each of these strategies of providing nutrition is safe for patients with no significant difference in glycemic control or adverse effects. There is also data to suggest that approximating a more physiologic nutrition schedule with periods of feeding and periods of fasting may optimize gastrointestinal and metabolic hormonal feedback loops thereby effecting outcomes such as gastrointestinal motility, protein synthesis, and glycemic control, among others. Circadian rhythm research supports a temporally restricted period of feeding as well. Furthermore, periods of scheduled fasting will allow for provision of care that is incompatible with enteral feeds, without interrupting administration of nutrition (for example, procedures or testing, incompatible medications, etc). Aims 1 and 2 will clarify whether an intermittent enteral nutrition schedule is acceptable to ICU staff and patients. Aims 3 and 4 will test whether this enteral feeding schedule is effective in providing patients with required nutrition and acceptable glycemic control. This pilot will set the stage for a randomized controlled trial further investigating superiority of intermittent feeding as compared with the current standard of continuous feeding.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Patients will receive total recommended nutrition divided into four equal meals, delivered at a rate of 400 cc/hr at 8:00, 12:00, 16:00, 20:00. Titration schedule will include administering 50% of volume for first two feeds, then 75%, and then 100%.
Yale New Haven Hospital
New Haven, Connecticut, United States
Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, United States
Proportion complete protocol
This is defined as the proportion of patients who continue to receive intermittent enteral feeds during the entire course of their enteral nutrition or seven days, whichever comes first.
Time frame: Up to 7 days
Proportion correct pump rate
This is defined as the proportion of the feeds that enteral feeding pump provides nutrition at appropriate rate.
Time frame: Up to 7 days
Proportion clogged enteral access
This is defined as the proportion of patients whose enteral access is clogged.
Time frame: Up to 7 days
Proportion completed meals
This is defined as the proportion of meals that are delivered.
Time frame: Up to 7 days
Staff satisfaction
This will be measured using a qualitative survey of bedside nurses and ICU nutritionists regarding perceptions of intervention feasibility.
Time frame: Up to 7 days
Proportion held to accommodate a medication
This is defined as the proportion of patients who had enteral nutrition held to accommodate a medication.
Time frame: Up to 7 days
Proportion held to accommodate a procedure
This is defined as the proportion of patients who had enteral nutrition held to accommodate a procedure.
Time frame: Up to 7 days
Early mobility
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Enrollment
14
This is defined as the proportion of patients able to participate in early mobility.
Time frame: Up to 7 days
Proportion feeding intolerance
This is defined as the proportion of patients with one or more of the following conditions: * New onset nausea or vomiting * Clinical concern for ileus or obstruction, as documented in progress notes * New onset abdominal distension, as documented in progress notes * Abdominal X-ray (not obtained for purposes of line/tube placement verification)
Time frame: Up to 7 days
Proportion Diarrhea
This is defined as the proportion of patients with diarrhea.
Time frame: Up to 7 days
Symptomatic elevated gastric residual volume
This is defined as the proportion of patients with gastric residual volume \>500 AND any of the following symptoms: * New onset nausea or vomiting * Clinical concern for ileus or obstruction, as documented in progress notes * New onset abdominal distension, as documented in progress notes * Abdominal X-ray (not obtained for purposes of line/tube placement verification)
Time frame: Up to 7 days
Percent of recommended nutrition delivered
This is defined as the average daily calorie intake as percentage of goal calories (determined by RD).
Time frame: Up to 7 days
Nutrition delay
This is defined as the time (hours) from intubation to patient receiving 50% of caloric needs.
Time frame: Up to 7 days
Adequate nutrition provision
This is defined as the proportion of days that patient is receiving enteral nutrition that at least 70% of caloric need is administered.
Time frame: Up to 7 days
Inadequate nutrition provision
This is defined as the proportion of days that patient is receiving enteral nutrition that less than 30% of caloric need is administered.
Time frame: Up to 7 days
Hyperglycemia proportion
This is defined as the proportion of glucose measurements closest to 8:00, 12:00, 16:00, 20:00 (including on basic metabolic panel and point of care testing) that are greater than or equal to 180.
Time frame: Up to 7 days
Insulin drip usage
This is defined as the proportion of glucose measurements closest to 8:00, 12:00, 16:00, 20:00 (including on basic metabolic panel and point of care testing) that are less than or equal to 60.
Time frame: Up to 7 days
Non-diabetic insulin usage proportion
This is defined as the proportion of patients who do not have a pre-existing diagnosis of diabetes mellitus who require any insulin dose.
Time frame: Up to 7 days