Reducing Delirium in the Surgical Intensive Care Unit

Study Overview
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Brief Summary
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Delirium is an acute disturbance in mental abilities and confusion that affects many patient in the hospital and is caused by multiple factors including and altered sleep/wake cycles and multiple sedating medications. Patients in the ICU are particularly susceptible to developing delirium due to increased noise levels and metabolic derangements. Numerous studies have shown that delirium can be associated with many negative outcomes, including longer hospital length of stay, increased time on a ventilator, higher mortality rates, and greater long-term cognitive dysfunction. There are a series of non-pharmacological interventions that have been shown to reduce delirium especially in intensive care units. These include noise reduction, frequent reorientation, reducing unnecessary stimulation at night, and grouping patient care procedures. The aim of this study is to evaluate the benefits of eye masks and earplugs (used concurrently) on reducing delirium and to assess for associated outcomes such as length of stay, use of sedating medications, morbidity, and mortality. The benefits of this are to improve sleep quality, and this intervention has been associated with a reduction in the risk of delirium.

Detailed Description
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Delirium is an acute disturbance in mental abilities and confusion that affects many patient in the hospital and is caused by multiple factors including and altered sleep/wake cycles and multiple sedating medications. Patients in the ICU are particularly susceptible to developing delirium due to increased noise levels and metabolic derangements. Numerous studies have shown that delirium can be associated with many negative outcomes, including longer hospital length of stay, increased time on a ventilator, higher mortality rates, and greater long-term cognitive dysfunction. There are a series of non-pharmacological interventions that have been shown to reduce delirium especially in intensive care units. These include noise reduction, frequent reorientation, reducing unnecessary stimulation at night, and grouping patient care procedures. The aim of this study is to evaluate the benefits of eye masks and earplugs on reducing delirium and to assess for associated outcomes such as length of stay, use of sedating medications, morbidity, and mortality. The benefits of this are to improve sleep quality, and this intervention has been associated with a reduction in the risk of delirium. Detailed Description: Patients eligible for this study will include patients admitted to either the Surgical ICU (SICU) or stepdown unit, under the care of the SICU care team, beginning on 8/1/16. Consent will be obtained from patients or their family members by study personnel. Data that will be collected include diagnosis on admission, any surgeries performed and their respective dates, length of stay in the SICU and step-down unit, use of sedating medication, and the Confusion Assessment Method (CAM) results. Subjects will also be asked to fill out 2 separate questionnaires about the quality of their sleep. The first questionnaire will be administered on enrollment and the second questionnaire will be administered upon discharge from the SICU. The rates of compliance of the use of earplugs and eye masks will also be assessed by means of a calendar checklist to be displayed at the patient's bedside. These outcomes will be compared to those of a historical control group not undergoing such interventions. The investigators aim to enroll 100 subjects and have a control group of another 100 patients retrospectively selected from matched patients over the previous year (8/1/15 - 8/1/16), before implementation of such interventions. The remainder of patient data will be collected by means of a retrospective chart review.

Official Title
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Reducing Delirium in the Surgical Intensive Care Unit Through the Use of Eye Masks and Earplugs

Conditions
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Delirium

Intervention / Treatment
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* Other: eye masks and earplugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Patient spending more than or equal to 24 hours in the SICU or stepdown unit Exclusion Criteria: Known pre-existing history of sleep pathology, severe visual or hearing impairment History of cognitive dysfunction (dementia, traumatic brain injury, stroke or hepatic encephalopathy, or intellectual disability) Admitted in delirious state Facial trauma involving orbits or auditory canals

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Earplugs and eye masks (to be used concurrently)<br>Group will include patients consented to the use of earplugs and eye masks. Patients will participate in the intervention nightly | Other: eye masks and earplugs<br>* Materials similar to those offered on long commercial flights<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | Daily assessment of delirium documented in the patient's chart | for the duration of a patient's hospital stay (1 day - 1 year) | 
| Length of stay |  | for the duration of a patient's hospital stay (1 day - 1 year) | 
| Sedative use | quantification of sedating medications used during a patient's hospital stay | for the duration of a patient's hospital stay (1 day - 1 year) | 
| CAM-ICU | documentation of the CAM-ICU scoring system for delirium on a daily basis in patient's chart | for the duration of a patient's hospital stay (1 day - 1 year) |