Effects of Feeding Schedule on the Development of ICU Delirium

This study will investigate if enteric feeding schedules alter the development of delirium in Intensive Care Unit patients who have been placed on mechanical ventilation. Delirium is an altered state of consciousness, which can involve agitation, inattention, and decreased awareness. We will enroll Intensive Care Unit patients who have been placed on a ventilator and are being given tube feedings. We will randomize participants into two groups: one group will receive continuous feedings via feeding tube, and the other group will receive feedings on a schedule to mimic breakfast, lunch, a snack, and dinner. Subjects will be assessed for the development of delirium. Subjects will also be monitored for sleep quality.

Study Overview

• Status: Recruiting
• Conditions: ICU Delirium
• Intervention / Treatment: Behavioral: Enteric feeding

Detailed Description

Patients will need to have at least 48 hours of enteric feedings to be included, and will be stratified by their APACHE IV score. Patients will be randomized into time restricted feeding vs continuous feeding by investigators, with no change in caloric intake nor nutrient content from orders. Patients will be assessed for delirium using the CAM-ICU (Confusion Assessment Method in the Intensive Care Unit) screening tool every twelve hours. At the time of the CAM ICU assessment, as part of the experimental design, the patient's sleep will be monitored by X8 Sleep Profiler device, placed and secured to their forehead, and the Sleep Profiler device will collect information regarding sleep quality as assessed by relative delta power, relative theta power and relative beta power.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deepali Dixit, PharmD; Phone Number: (848) 445-6825; Email: ddixit@pharmacy.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Robert Wood Johnson University Hospital
      • Contact: Deepali Dixit, PharmD; Phone Number: 848-445-6825

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Admitted to the ICU
• Mechanically ventilated
• Receiving enteric feedings for at least 48 hours

Exclusion Criteria:

• Pregnancy
• Previously diagnosed neurocognitive disorders,
• Alcohol withdrawal and history of alcohol dependence

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Continuous Feeding; Enteric feeding will be given continuously.
Experimental: Timed Feeding; Enteric feeding will be given four times per day, approximating breakfast, lunch, a snack, and dinner.	Behavioral: Enteric feeding; All subjects will be given nutrition enterally, corresponding to their calculated nutritional needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients developing delirium.	The development of delirium as measured by the CAM-ICU (Confusion Assessment Method for the ICU) protocol. The percent of patients developing delirium will be assessed in each arm. Delirium will be assessed every 12 hours.	48 hours after admission to the ICU.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep quality assessed using delta power.	Change in relative delta power on EEG will be assessed in each arm.	Measurement will be made from study enrollment to extubation, up to 1 week.
Change in sleep quality assessed using theta power.	Change in relative theta power on EEG will be assessed in each arm.	Measurement will be made from study enrollment to extubation, up to 1 week.
Change in sleep quality using beta power.	Change in relative beta power on EEG will be assessed in each arm.	Measurement will be made from study enrollment to extubation, up to 1 week.

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Deepali Dixit, PharmD, Rutgers Ernest Mario School of Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Estimated): April 26, 2024
• Study Completion (Estimated): April 26, 2024

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Tube feeds
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: Pro2018001273

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