Effects of Feeding Schedule on the Development of ICU Delirium

Rutgers The State University of New Jersey

Status: Terminated

Conditions: ICU Delirium

Treatments: Behavioral: Enteric feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT04870554

Pro2018001273

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

Continuous Feeding

No Intervention group

Description:

Enteric feeding will be given continuously.

Timed Feeding

Experimental group

Description:

Enteric feeding will be given four times per day, approximating breakfast, lunch, a snack, and dinner.

Treatment:

Behavioral: Enteric feeding