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Completed

NCT Number: NCT03313115

Sleep/Wake Protocol Implementation to Improve Sleep Quality in the ICU

The purpose of this study is to analyze a multi-component sleep/wake protocol for optimization of environmental factors (noise, light, nursing activities) as well as non-environmental factors (pain, mechanical support devices, procedures) to improve quality of sleep and decrease incidence of ICU delirium in the Cardiovascular and Surgical ICU (CVICU/SICU).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

Fifty-percent of ICU patient sleep hours occur during the day in short bouts which decreases overall sleep quality. Approximately 47-87% of critically ill patients in the ICU experience an episode of delirium, which can result in changes in cognition, longer hospital stay, and physiologic consequences. Research suggests that both patients and staff members can identify environmental factors, such as noise, light, and nursing activities, as well as non-environmental factors such as mechanical devices, procedures, and medications as contributing factors to lack of sleep. However, both nursing staff and providers may underestimate the intensity of the perceived noise in the ICU. This includes those frequent nighttime interruptions, of environmental and non-environmental origins, which can cause fragmented sleep. Providers and nurses are aware of the factors contributing to sleep deprivation, but they may "lower prioritization of patient sleep [as a] tradeoff [for] current standard of care."

Studies have shown that sleep deprivation in critically ill patients can lead to changes in patient cognition, increased hospital and ICU length of stay, and physiologic consequences. These consequences are influenced from patient clinical status as well as modifiable risk factors. One study identified that barriers to the optimization of sleep include patient disease severity, mechanical ventilation, sedation, noise, light, and nurse-patient interaction. It identified a possible association between lack of sleep and cognition with additional consequences of longer mechanical ventilator time, and cardiovascular, pulmonary, and immune system dysfunctions.

Implementation of a protocol directed at optimizing environmental and non-environmental factors has been shown to improve patients' perceived and actual quality of sleep as well as a reduction in ICU delirium.

Another study studied sleep and delirium in a medical ICU after implementation of sleep-promoting interventions. Interventions aimed at reducing light, noise, nursing interruptions, and sedating medications were applied in a three-part process. Patients were surveyed using the Richards-Campbell Sleep Questionnaire and delirium was measured by delirium/coma-free days. Post-interventions resulted in an increase in delirium/coma-free days and an improvement in the amount of perceived noise.

One research group implemented a similar bundle that was aimed at improvement of sleep and delirium in both medical and surgical ICU patients. Their efforts were directed towards reduction in environmental factors as well as avoidance of sedating medications and long mechanical ventilator times. The Richards-Campbell Sleep Questionnaire was used to survey patients on quality of sleep and the Confusion Assessment Method for the ICU was measured daily for incidence of delirium. They found that patients' perceived quality of sleep increased with decreased daytime sleepiness as well as reductions in noise, light, and nursing interventions. Furthermore, they found that implementation of this bundle led to a decrease in length of delirium.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Admitted to the cardiovascular or surgical ICU

Exclusion criteria

  • Patient acuity does not allow nighttime activities to be grouped (i.e., patient requires frequent bedside care throughout the night, as evaluated by registered nurse)

Treatment and study plan

Sleep/Wake Protocol

Behavioral

Day RN observes if completed per pt: no caffeine after 3 pm, encourage activities to prevent napping (chart % day spent napping), Lights on blinds/door open, Reasonable effort for some noise in room, Eye glasses hearing aids applied, Chair position/mobility at least 2x30 minutes.

Night RN observe if completed per pt: Appropriate pain control, Optimize room temp, Warm bath before 2200, TV off by 2200, Prevent extra alarms after 2200, Close room curtain by 2200, Dim room lights by 2200, Family out by 2200, Door half/fully closed after 2200, # RN interruptions after 2200, Offer eye mask/ear plugs, Meds administered for sleep (dilaudid, fentanyl oxycodone, haldol, quetiapine, propofol, melatonin, or other), Dim hallway lights by 2200, Nurses station quiet

Primary outcomes

  1. Incidence of ICU delirium

    Time frame: Two times daily until ICU discharge (up to 4 months)

    Participants will be evaluated for delirium using the Confusion Assessment Method for the ICU (CAM-ICU)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Sleep/Wake Protocol Implementation to Improve Sleep Quality and Reduce Delirium in a Surgical and Cardiovascular Intensive Care Unit

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2017
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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