Pilot: Feasibility of Intermittent Enteral Feeding in Ventilated MICU Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Nutrition
• Intervention / Treatment: Dietary supplement: Intermittent Enteral Nutrition Protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital, York Street Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent feed participants; 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; 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%.
No Intervention: Control participants; 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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Shyoko Honiden, MD, Program Director, Pulmonary & Critical Care Medicine Program, Internal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Actual): March 18, 2020
• Study Completion (Actual): March 18, 2020

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: intensive care unit
• Other Study ID Numbers: IRB Exempt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No