ICU Delirium
Conditions
Keywords
Mechanical ventilation, Tube feeds
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.
Interventions
BEHAVIORALEnteric feeding
All subjects will be given nutrition enterally, corresponding to their calculated nutritional needs.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants will be under sedation. The outcome assessor for delirium (primary outcome) is not blinded. Assessors rating the sleep quality (secondary outcome) will be blinded.
Intervention model description
Patients will be randomly assigned to one of two treatment groups: standard continuous feeding or timed feeding.
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed