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Reducing Delirium in the Surgical Intensive Care Unit

Primary Purpose

Delirium

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eye masks and earplugs
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Delirium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Earplugs and eye masks (to be used concurrently)

Arm Description

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

Outcomes

Primary Outcome Measures

Delirium
Daily assessment of delirium documented in the patient's chart
Length of stay
Sedative use
quantification of sedating medications used during a patient's hospital stay
CAM-ICU
documentation of the CAM-ICU scoring system for delirium on a daily basis in patient's chart

Secondary Outcome Measures

Full Information

First Posted
August 1, 2016
Last Updated
July 7, 2017
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02856737
Brief Title
Reducing Delirium in the Surgical Intensive Care Unit
Official Title
Reducing Delirium in the Surgical Intensive Care Unit Through the Use of Eye Masks and Earplugs
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
inadequate personel
Study Start Date
August 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Earplugs and eye masks (to be used concurrently)
Arm Type
Experimental
Arm Description
Group will include patients consented to the use of earplugs and eye masks. Patients will participate in the intervention nightly
Intervention Type
Other
Intervention Name(s)
eye masks and earplugs
Intervention Description
Materials similar to those offered on long commercial flights
Primary Outcome Measure Information:
Title
Delirium
Description
Daily assessment of delirium documented in the patient's chart
Time Frame
for the duration of a patient's hospital stay (1 day - 1 year)
Title
Length of stay
Time Frame
for the duration of a patient's hospital stay (1 day - 1 year)
Title
Sedative use
Description
quantification of sedating medications used during a patient's hospital stay
Time Frame
for the duration of a patient's hospital stay (1 day - 1 year)
Title
CAM-ICU
Description
documentation of the CAM-ICU scoring system for delirium on a daily basis in patient's chart
Time Frame
for the duration of a patient's hospital stay (1 day - 1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie D Talutis, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12752832
Citation
McNicoll L, Pisani MA, Zhang Y, Ely EW, Siegel MD, Inouye SK. Delirium in the intensive care unit: occurrence and clinical course in older patients. J Am Geriatr Soc. 2003 May;51(5):591-8. doi: 10.1034/j.1600-0579.2003.00201.x.
Results Reference
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PubMed Identifier
24401069
Citation
Pandharipande PP, Girard TD, Ely EW. Long-term cognitive impairment after critical illness. N Engl J Med. 2014 Jan 9;370(2):185-6. doi: 10.1056/NEJMc1313886. No abstract available.
Results Reference
background
PubMed Identifier
26596509
Citation
Rivosecchi RM, Kane-Gill SL, Svec S, Campbell S, Smithburger PL. The implementation of a nonpharmacologic protocol to prevent intensive care delirium. J Crit Care. 2016 Feb;31(1):206-11. doi: 10.1016/j.jcrc.2015.09.031. Epub 2015 Oct 17.
Results Reference
background
PubMed Identifier
24813132
Citation
Patel J, Baldwin J, Bunting P, Laha S. The effect of a multicomponent multidisciplinary bundle of interventions on sleep and delirium in medical and surgical intensive care patients. Anaesthesia. 2014 Jun;69(6):540-9. doi: 10.1111/anae.12638.
Results Reference
background
PubMed Identifier
25887528
Citation
Huang HW, Zheng BL, Jiang L, Lin ZT, Zhang GB, Shen L, Xi XM. Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment: which might be a more promising strategy for ICU sleep deprivation? Crit Care. 2015 Mar 19;19(1):124. doi: 10.1186/s13054-015-0842-8.
Results Reference
background
PubMed Identifier
26741578
Citation
Litton E, Carnegie V, Elliott R, Webb SA. The Efficacy of Earplugs as a Sleep Hygiene Strategy for Reducing Delirium in the ICU: A Systematic Review and Meta-Analysis. Crit Care Med. 2016 May;44(5):992-9. doi: 10.1097/CCM.0000000000001557.
Results Reference
background
PubMed Identifier
22559080
Citation
Van Rompaey B, Elseviers MM, Van Drom W, Fromont V, Jorens PG. The effect of earplugs during the night on the onset of delirium and sleep perception: a randomized controlled trial in intensive care patients. Crit Care. 2012 May 4;16(3):R73. doi: 10.1186/cc11330.
Results Reference
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Reducing Delirium in the Surgical Intensive Care Unit

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