NCT03313115

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
685

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2018

Completed
Last Updated

April 25, 2023

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

October 11, 2017

Last Update Submit

April 21, 2023

Conditions

Sleep DeprivationDelirium

Outcome Measures

Primary Outcomes (1)

  • Incidence of ICU delirium

    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)

Study Arms (2)

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

Interventions

Sleep/Wake ProtocolBEHAVIORAL

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

Sleep/Wake Protocol Implementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (14)

  • Beltrami FG, Nguyen XL, Pichereau C, Maury E, Fleury B, Fagondes S. Sleep in the intensive care unit. J Bras Pneumol. 2015 Nov-Dec;41(6):539-46. doi: 10.1590/S1806-37562015000000056.

    PMID: 26785964BACKGROUND

  • Bihari S, Doug McEvoy R, Matheson E, Kim S, Woodman RJ, Bersten AD. Factors affecting sleep quality of patients in intensive care unit. J Clin Sleep Med. 2012 Jun 15;8(3):301-7. doi: 10.5664/jcsm.1920.

    PMID: 22701388BACKGROUND

  • Cavallazzi R, Saad M, Marik PE. Delirium in the ICU: an overview. Ann Intensive Care. 2012 Dec 27;2(1):49. doi: 10.1186/2110-5820-2-49.

    PMID: 23270646BACKGROUND

  • Giusti GD, Tuteri D, Giontella M. Nursing Interactions With Intensive Care Unit Patients Affected by Sleep Deprivation: An Observational Study. Dimens Crit Care Nurs. 2016 May-Jun;35(3):154-9. doi: 10.1097/DCC.0000000000000177.

    PMID: 27043401BACKGROUND

  • Hata RK, Han L, Slade J, Miyahira A, Passion C, Ghows M, Izumi K, Yu M. Promoting sleep in the adult surgical intensive care unit patients to prevent delirium. Nurs Clin North Am. 2014 Sep;49(3):383-97. doi: 10.1016/j.cnur.2014.05.012.

    PMID: 25155537BACKGROUND

  • Hopper K, Fried TR, Pisani MA. Health care worker attitudes and identified barriers to patient sleep in the medical intensive care unit. Heart Lung. 2015 Mar-Apr;44(2):95-9. doi: 10.1016/j.hrtlng.2015.01.011. Epub 2015 Feb 14.

    PMID: 25686516BACKGROUND

  • Kamdar BB, Needham DM, Collop NA. Sleep deprivation in critical illness: its role in physical and psychological recovery. J Intensive Care Med. 2012 Mar-Apr;27(2):97-111. doi: 10.1177/0885066610394322. Epub 2011 Jan 10.

    PMID: 21220271BACKGROUND

  • Kamdar BB, King LM, Collop NA, Sakamuri S, Colantuoni E, Neufeld KJ, Bienvenu OJ, Rowden AM, Touradji P, Brower RG, Needham DM. The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Crit Care Med. 2013 Mar;41(3):800-9. doi: 10.1097/CCM.0b013e3182746442.

    PMID: 23314584BACKGROUND

  • 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: 24813132BACKGROUND

  • Pulak LM, Jensen L. Sleep in the Intensive Care Unit: A Review. J Intensive Care Med. 2016 Jan;31(1):14-23. doi: 10.1177/0885066614538749. Epub 2014 Jun 10.

    PMID: 24916753BACKGROUND

  • Ritmala-Castren M, Virtanen I, Leivo S, Kaukonen KM, Leino-Kilpi H. Sleep and nursing care activities in an intensive care unit. Nurs Health Sci. 2015 Sep;17(3):354-61. doi: 10.1111/nhs.12195. Epub 2015 Mar 18.

    PMID: 25786544BACKGROUND

  • Weinhouse GL, Schwab RJ. Sleep in the critically ill patient. Sleep. 2006 May;29(5):707-16. doi: 10.1093/sleep/29.5.707.

    PMID: 16774162BACKGROUND

  • White BL, Zomorodi M. Perceived and actual noise levels in critical care units. Intensive Crit Care Nurs. 2017 Feb;38:18-23. doi: 10.1016/j.iccn.2016.06.004. Epub 2016 Aug 25.

    PMID: 27567305BACKGROUND

  • Tonna JE, Dalton A, Presson AP, Zhang C, Colantuoni E, Lander K, Howard S, Beynon J, Kamdar BB. The Effect of a Quality Improvement Intervention on Sleep and Delirium in Critically Ill Patients in a Surgical ICU. Chest. 2021 Sep;160(3):899-908. doi: 10.1016/j.chest.2021.03.030. Epub 2021 Mar 24.

    PMID: 33773988DERIVED

MeSH Terms

Conditions

Sleep DeprivationDelirium

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersConfusionNeurobehavioral ManifestationsNeurocognitive Disorders

Study Officials

  • Joseph Tonna, MD, FAAEM

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 18, 2017

Study Start

October 11, 2017

Primary Completion

March 14, 2018

Study Completion

March 14, 2018

Last Updated

April 25, 2023

Record last verified: 2020-02

Locations

US(1)