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

NCT04437264 | Completed

• 1 other identifier: 2000027328
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Feeding; Nutrition Disorders

Outcome Measures

Primary Outcomes (1)

• Recommended calories

  percentage of recommended calories that patient receives per day of interest during study period

  Intubation day 1 to intubation day 10

Secondary Outcomes (8)

• Percentage of patients with aspiration

  Intubation day 1 to intubation day 10

• Percentage of patients experiencing intolerance of feeding

  Intubation day 1 to intubation day 10

• feasibility: proportion complete protocol

  Intubation day 1 to intubation day 10

• delirium

  intubation day 1 until 14 days later

• urine 6-sulfatoxymelatonin acrophase

  day 1 to 3 following initiation of feeds

Study Arms (2)

Intermittent feed

EXPERIMENTAL

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 Supplement: Intermittent feed participant

Continuous feeds

EXPERIMENTAL

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.

Dietary Supplement: Continuous feeds participant

Interventions

Intermittent feed participant DIETARY_SUPPLEMENT

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.

Intermittent feed

Continuous feeds participant DIETARY_SUPPLEMENT

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.

Continuous feeds

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient has opted out of research participation via institutional patient portal.
• At significant risk for gastrointestinal intolerance of intermittent bolus feeds:
• Structural gastrointestinal obstruction (such as tumor).
• Chronic enteral nutrition (prior to current admission).
• History of significant esophageal dysmotility (history of GERD is acceptable) or clinically significant GE junction incompetence
• Unable to have head of bed elevated at least 30 degrees while intubated and being fed (this is standard protocol).
• History of small bowel obstruction or ileus on current admission or within last 1 month.
• History of gastroparesis.
• Percutaneous gastrostomy tube or tracheostomy.
• History of ongoing aspiration as determined by a speech medicine specialist or other medical professional or a patent who required adjustment of diet (e.g., thickening of liquids) prior to hospitalization.
• History of significant esophageal dysmotility (history of GERD is acceptable) or clinically significant GE junction incompetence
• At risk of refeeding syndrome.
• Pregnant patients.
• Patients receiving neuromuscular blockade.
• Patients with glycemic emergency (HHNK, DKA, severe hypoglycemia resulting in MICU admission) or patients controlling their sugar / insulin dosing via continuous glucose monitoring

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Melissa P Knauert, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 18, 2020
• Study Start: July 7, 2020
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)