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Trained study staff left the study and we had difficulty recruiting patients.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Feeding | No Intervention | Enteric feeding will be given continuously. | |
| Timed Feeding | Experimental | Enteric feeding will be given four times per day, approximating breakfast, lunch, a snack, and dinner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric feeding | Behavioral | All subjects will be given nutrition enterally, corresponding to their calculated nutritional needs. |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepali Dixit, PharmD | Rutgers Ernest Mario School of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38112772 | Derived | Luetz A, Spies C, Kervezee L. It's about time: circadian medicine in the intensive care unit. Intensive Care Med. 2024 Feb;50(2):283-286. doi: 10.1007/s00134-023-07297-0. Epub 2023 Dec 19. No abstract available. |
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Patients will be randomly assigned to one of two treatment groups: standard continuous feeding or timed feeding.
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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.
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. |