Direct Noise Reduction in the Intensive Care Units (ICU) Using Earplugs and Noise Canceling Headphones
| Status: | Terminated |
|---|---|
| Conditions: | Insomnia Sleep Studies, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/14/2018 |
| Start Date: | May 2011 |
| End Date: | June 2015 |
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
This study seeks to examine the effects of overnight noise reduction in critically ill
patients who are receiving mechanical ventilation. The investigators will randomly place
subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs
and noise-canceling headphones. The investigators will monitor for safety, and will measure
the amount of delirium experienced by subjects, record the amount of sedating and painkilling
medicines required, and measure sleep quality during the study, among other information. The
investigators will also measure noise levels experienced by patients in each group. The
investigators predict that the use of overnight noise reduction will be safe and will reduce
the amount of delirium by improving the quality of sleep in critically ill patients.
patients who are receiving mechanical ventilation. The investigators will randomly place
subjects into one of three groups: 1) usual care 2) overnight earplugs 3) overnight earplugs
and noise-canceling headphones. The investigators will monitor for safety, and will measure
the amount of delirium experienced by subjects, record the amount of sedating and painkilling
medicines required, and measure sleep quality during the study, among other information. The
investigators will also measure noise levels experienced by patients in each group. The
investigators predict that the use of overnight noise reduction will be safe and will reduce
the amount of delirium by improving the quality of sleep in critically ill patients.
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.
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.
Inclusion Criteria:
- Adult patients who are admitted to our MICU for at least 24 hours with at least 72
hours' additional expected stay in ICU, and who are mechanically ventilated
Exclusion Criteria:
- severe to profound hearing loss
- baseline use of hearing aids
- eardrum perforation
- severe cerumen impaction
- head or oromaxillofacial trauma
- external ventricular drain or intracranial pressure monitoring devices
- comatose patients who are deemed by their attending physician as unlikely to awaken
within 72 hours
- patient status as comfort-measures only
- any other contraindication to the use of earplugs or headphones
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