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Intermittent Versus Continuous Enteral Nutrition in Mechanically Ventilated Patients in the Medical Intensive Care Unit

Intermittent Versus Continuous Enteral Nutrition in Mechanically Ventilated Patients in the Medical Intensive Care Unit

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04437264
Enrollment
20
Registered
2020-06-18
Start date
2020-07-07
Completion date
2022-12-07
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Feeding, Nutrition Disorders

Brief summary

Evaluate effective delivery of goal nutrition with intermittent as compared with continuous enteral nutrition schedules, as defined by percentage of recommended calories that patient receives per day of interest.

Detailed description

Eligible patients will be approached and if the patient (or surrogate decision maker) is interested, then consent will be obtained for participation in the study. The patient will then be randomly assigned to receive usual care (continuous feeds) or intervention (intermittent feeds, see details below). Randomization will occur via simple block randomization within the REDCap software. Group assignment will not be revealed to the clinical team until the decision to feed the patient has occurred and the actual feeding order is entered. When the clinical team decides to initiate enteral nutrition, they will place a nutrition consult order for tube feed recommendations. Nutrition consult will place recommendations for both continuous feeding and for intermittent schedule, including enteral nutrition formula and dosing. Prior to feeds being started, the patient's randomization status will be revealed to the clinical team. The covering provider will then place the order for enteral nutrition according to the nutritionist's recommendations for the correct feeding schedule. For patients randomized to continuous feeds, their enteral nutrition will be ordered and delivered as per usual care and standard MICU procedure. Nutritionist will provide recommendations for initiation rate, up titration schedule, and maintenance dosing to be delivered continuously over 24 hours. Under usual care of ICU patients, our clinical nutritionists provide a specified formula, a specified calorie goal, and a suggested titration rate. This is typically 20 mL per hour to start with an increase in rate of 20 mL per hour every 6 to 8 hours until the goal rate is achieved. Typical goal rates are in the range of 60 to 80 mL per hour for 24 hours per day. For patients randomized to the intervention group (intermittent feeds), they will receive their enteral nutrition according to a research protocol schedule. This will involve the total recommended feed volume divided into four equal volume meals. These will be delivered at a rate of 400 cc/hr at 8:00, 12:00, 16:00, and 20:00. The up-titration schedule will be as follows: first meal will be 100 mL, and the volume of each meal thereafter will be increased by 100mL until patient is at goal volume (typically between 300 and 450 mL). There are no formula or diets that are inappropriate to be administered on an intermittent feed schedule. The intervention will not change formula selection or total calorie goals. It will only change the schedule of feeding. For all patients, regardless of feeding schedule, the Kangaroo E-Pump will be used to deliver enteral nutrition, and the above rate and volume parameters can be programmed in. There will be no change in delivery of enteral free water or medications. This schedule will be determined by nursing and clinical care team, as is the current standard of care. To assure correct ordering of intermittent feeds and the insulin prior to each meal, an EPIC orderset with prepopulated instructions will be developed. If there are no signs of or clinical concerns for intolerance, patients will continue to receive enteral nutrition according to assigned schedule until they are extubated or until enteral nutrition is discontinued.

Interventions

DIETARY_SUPPLEMENTIntermittent feed participant

Patients 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_SUPPLEMENTContinuous feeds participant

Patients will be assigned to receive continuous enteral feeding protocol. Typical goal rates are in the range of 60 to 80 mL per hour for 24 hours per day.

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The care team and study staff in the ICU will be aware of arm assignment. Study staff abstracting outcome data will be blinded to arm assignement.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* MICU Yale New Haven Hospital * Age \>= 18 years old. * Patients mechanically ventilated via endotracheal tube * Patients intubated within 72 hours of hospital admission * First intubation of current hospitalization * First MICU admission of current hospitalization

Exclusion criteria

• Patient has opted out of research participation via institutional patient portal. At significant risk for gastrointestinal intolerance of intermittent bolus feeds: * Prior upper gastrointestinal surgery that alters proximal GI anatomy (including but not limited to gastric bypass surgery, gastric banding, complete or partial gastrectomy, Whipple procedure; of note, appendectomy and cholecystectomy are not

Design outcomes

Primary

MeasureTime frameDescription
Recommended caloriesIntubation day 1 to intubation day 10percentage of recommended calories that patient receives per day of interest during study period

Secondary

MeasureTime frameDescription
Percentage of patients experiencing intolerance of feedingIntubation day 1 to intubation day 10percentage of patients experiencing intolerance of feeding including nausea, vomiting, diarrhea, ileus
feasibility: proportion complete protocolIntubation day 1 to intubation day 10percentage of patients assigned to intervention (ie intermittent feeding protocol) that remain on study protocol for study period of interest.
deliriumintubation day 1 until 14 days laternumber of delirium and coma free days out of 14 following intubation
Percentage of patients with aspirationIntubation day 1 to intubation day 10percentage of patients experiencing aspiration
maximum glucoseIntubation day 1 to intubation day 10highest glucose per day of interest
minimum glucoseIntubation day 1 to intubation day 10lowest glucose per day of interest
insulin usageIntubation day 1 to intubation day 10number of insulin units used per day (composite of short and long acting formulations)
urine 6-sulfatoxymelatonin acrophaseday 1 to 3 following initiation of feedsUrine 6-sulfatoxymelatonin acrophase defined as the time of fitted peak 6-sulfatoxymelatonin from fitting a cosine curve to hourly urine aMT6s levels will be determined daily

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026