Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones
Device: Foam Earplugs
Device: Noise Canceling Headphones
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Randomized Controlled Trial of Direct Noise Reduction in the ICU Using Overnight Application of In-ear Earplugs or In-ear Earplugs Plus Noise-Canceling Headphones to Reduce the Incidence and Duration of ICU Delirium|
- Days Free of Delirium or coma [ Time Frame: During the Study Period (Study Days 0-7) ] [ Designated as safety issue: Yes ]
- Noise Attenuation [ Time Frame: Overnight (10pm-6am) on study day 2 or 3. ] [ Designated as safety issue: No ]The reduction in noise experienced by the subject when using the study intervention.
- Sleep Efficiency and Architecture [ Time Frame: Overnight (10pm-6am) on study day 2 or 3 ] [ Designated as safety issue: No ]Staging of sleep with efficiency determined as a ratio of total sleep time/total study time.
- Amount of sedative use [ Time Frame: During the Study Period (Study Days 0-7) ] [ Designated as safety issue: Yes ]
- Amount of analgesic use [ Time Frame: During the Study Period (Study Days 0-7) ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
No Intervention: Usual Care
Usual Care between 10pm-6am
Active Comparator: Earplugs
Application of earplugs from 10pm-6am nightly for seven nights or until ICU discharge.
Device: Foam Earplugs
Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
Active Comparator: Earplugs and Headphones
Earplugs and Noise-canceling headphones applied from 10pm-6am nightly for 7 nights or until ICU discharge.
Device: Foam Earplugs
Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)Device: Noise Canceling Headphones
Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.
Delirium is an acute confusional state defined by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. Acute delirium is an increasingly recognized problem in intensive care units (ICUs) in the US and worldwide. ICU Delirium has been estimated to occur in as many as 50 to 80 percent of ICU patients. Delirium in the ICU has been associated with worsened clinical outcomes such as prolonged hospitalization and death [1-4]. Although noise has been shown to negatively influence sleep in the ICU, and sleep disturbance is a recognized contributor to ICU delirium[1-2, 4], there is no well-established link between ICU noise levels and the development of ICU delirium. Optimal strategies for the prevention and treatment of ICU delirium are yet to be defined, and this study will focus on a novel noise-reduction approach which has potential to impact both prevention and treatment [5-8]. Findings will be generalizable to other tertiary care medical intensive care units caring for adult patients.
Objectives Our multidisciplinary team will evaluate the safety and feasibility of direct noise reduction in the Wake Forest University Baptist Medical Center (WFUBMC) Medical Intensive Care Unit (MICU), and any effect on the incidence of ICU delirium.
Methods and Measures Design
- Forty-five (45) patients receiving mechanical ventilation will be randomized to receive either passive direct noise reduction (earplugs), both passive and active direct noise reduction (earplugs and noise-canceling headphones), or no direct noise reduction (usual practice).
- Ambient noise levels and the reduction in noise accomplished by direct noise reduction will be measured according to standardized audiometric techniques.
- Sleep structure, including amount of recovery sleep, will be measured over one night according to standardized polysomnographic (sleep study) techniques
- The incidence of delirium will be assessed as well as multiple other endpoints including but not limited to amount of psychoactive medication prescribed and amount of physical restraints required.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343095
|United States, North Carolina|
|Wake Forest Baptist Medical Center|
|Winston Salem, North Carolina, United States, 27157|
|Study Director:||Matthew C Miles, MD||Wake Forest School of Medicine|