Effects of Feeding Schedule on the Development of ICU Delirium

Not Applicable

Terminated

• Conditions: ICU Delirium
• Interventions: Behavioral: Enteric feeding

• Registration Number: NCT04870554
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-04-23
• Study Start: 2021-04-26
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Primary Completion: 2024-06-03
• Study Completion: 2024-06-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Timed Feeding	Enteric feeding	Enteric feeding will be given four times per day, approximating breakfast, lunch, a snack, and dinner.

Primary Outcome Measures

Name	Time	Method
Percent of patients developing delirium.	48 hours after admission to the ICU.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States