Clinical trial NCT04870554: Effects of Feeding Schedule on the Development of ICU Delirium
Official title: Effects of Feeding Schedule on the Development of ICU Delirium
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ICU Delirium
Keywords: Mechanical ventilation
Tube feeds
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to one of two treatment groups: standard continuous feeding or timed feeding.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of patients developing delirium.
timeFrame: 48 hours after admission to the ICU.
Secondary outcomes:
measure: Change in sleep quality assessed using delta power.
timeFrame: Measurement will be made from study enrollment to extubation, up to 1 week.
measure: Change in sleep quality assessed using theta power.
timeFrame: Measurement will be made from study enrollment to extubation, up to 1 week.
measure: Change in sleep quality using beta power.
timeFrame: Measurement will be made from study enrollment to extubation, up to 1 week.
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers Ernest Mario School of Pharmacy
name: Deepali Dixit, PharmD
role: PRINCIPAL_INVESTIGATOR
References: