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Clinical Trials/NCT02856737
NCT02856737WithdrawnNot Applicable

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

Boston Medical Center1 site in 1 countryStarted: August 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Sedative use

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Arms & Interventions

Earplugs and eye masks (to be used concurrently)

Experimental

Group will include patients consented to the use of earplugs and eye masks. Patients will participate in the intervention nightly

Intervention: eye masks and earplugs (Other)

Outcomes

Primary Outcomes

Sedative use

Time Frame: for the duration of a patient's hospital stay (1 day - 1 year)

quantification of sedating medications used during a patient's hospital stay

Length of stay

Time Frame: for the duration of a patient's hospital stay (1 day - 1 year)

Delirium

Time Frame: for the duration of a patient's hospital stay (1 day - 1 year)

Daily assessment of delirium documented in the patient's chart

CAM-ICU

Time Frame: for the duration of a patient's hospital stay (1 day - 1 year)

documentation of the CAM-ICU scoring system for delirium on a daily basis in patient's chart

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stephanie Talutis

Fellow in the Study of Quality and Patient Safety

Boston Medical Center

Study Sites (1)

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