Reducing Delirium in the Surgical Intensive Care Unit

NCT02856737 | Withdrawn

• 1 other identifier: SICU Delirium
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (1)

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

Other: eye masks and earplugs

Interventions

eye masks and earplugs OTHER

Materials similar to those offered on long commercial flights

Earplugs and eye masks (to be used concurrently)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Patient spending more than or equal to 24 hours in the SICU or stepdown unit

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (7)

• 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.

  PMID: 12752832 BACKGROUND

• 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.

  PMID: 24401069 BACKGROUND

• 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.

  PMID: 26596509 BACKGROUND

• 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.

  PMID: 24813132 BACKGROUND

• 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.

  PMID: 25887528 BACKGROUND

• 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.

  PMID: 26741578 BACKGROUND

• 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.

  PMID: 22559080 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Stephanie D Talutis, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in the Study of Quality and Patient Safety

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 5, 2016
• Study Start: August 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)