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

April 21, 2023 updated by: University of Utah

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

685

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study participants will be drawn from those admitted into the Cardiovascular or Surgical Intensive Care Units at the University of Utah University Hospital

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Sleep/Wake Protocol Implementation
No implementation of the sleep/wake protocol. A subset of participants in this group will have light and sound levels in the room recorded.
Sleep/Wake Protocol Implementation
The sleep/wake protocol will be implemented. A subset of participants in this group will also have light and sound levels in the room recorded.
Behavioral: Sleep/Wake Protocol

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Two times daily until ICU discharge (up to 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Joseph Tonna, MD, FAAEM, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2017

Primary Completion (Actual)

March 14, 2018

Study Completion (Actual)

March 14, 2018

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104449

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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