Pilot: Feasibility of Intermittent Enteral Feeding in Ventilated MICU Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Pilot Study to Assess the Feasibility and Safety of Intermittent Enteral Feeding in Mechanically Ventilated Medical Intensive Care Unit Patients

Conditions
-----------------
Nutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Intermittent Enteral Nutrition Protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical intensive care unit patients located in Yale-New Haven Hospital, York Street campus, North Pavilion 9 or 10. Hospitalized for less than or equal to 72 hours. Patients who are mechanically ventilated via endotracheal tube for at least 24 hours. Patients must have enteral access (nasogastric tube, orogastric tube). Team plans to initiate tube feeds. Exclusion Criteria: Prior upper gastrointestinal surgery (including but not limited to gastric bypass surgery, gastric banding, complete or partial gastrectomy, Whipple procedure; cholecystectomy is acceptable). Chronic enteral nutrition (prior to current admission). History of significant esophageal dysmotility (history of GERD is acceptable). Unable to have head of bed elevated at least 30 degrees while intubated and being fed (this is standard protocol). Enteral access terminates post-pyloric (ie nasojejunal or jejunostomy tubes are to be excluded). Pre-existing percutaneous gastrostomy tube. History of small bowel obstruction or ileus on current admission. History of gastroparesis. Clinical care team is not planning to initiate enteral nutrition. At risk of refeeding syndrome. Pregnant patients. Patients receiving neuromuscular blockade. Patients with glycemic emergency (HHNK, DKA, severe hypoglycemia resulting in MICU admission). Patients otherwise excluded by the treating physician.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent feed participants<br>Patients admitted to medical ICU #1 (of 2 at our hospital) will be assigned to receive intermittent enteral feeding protocol. They will receive four equal volume feeds at 8:00, 12:00, 16:00, and 20:00 hours. | Dietary Supplement: Intermittent Enteral Nutrition Protocol<br>* 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%.<br>|
| No Intervention: Control participants<br>Patients admitted to the medical ICU #2 (of 2 at our hospital) will receive usual care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion correct pump rate | This is defined as the proportion of the feeds that enteral feeding pump provides nutrition at appropriate rate. | Up to 7 days | 
| Proportion clogged enteral access | This is defined as the proportion of patients whose enteral access is clogged. | Up to 7 days | 
| Proportion completed meals | This is defined as the proportion of meals that are delivered. | 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. | 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. | 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. | Up to 7 days | 
| Early mobility | This is defined as the proportion of patients able to participate in early mobility. | 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) | Up to 7 days | 
| Proportion Diarrhea | This is defined as the proportion of patients with diarrhea. | 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) | 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). | Up to 7 days | 
| Nutrition delay | This is defined as the time (hours) from intubation to patient receiving 50% of caloric needs. | 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. | 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. | 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. | 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. | 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. | Up to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care unit