Protocol For Sleep for Critically Ill Patients

NCT05996861 | Unknown

• 1 other identifier: 842
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Sleep is essential for health and well-being. The quality of sleep impacts physical and cognitive aspects, including memory, immune system, and neuroendocrine function, with abnormalities associated with cardiovascular changes, neuropsychiatric disorders, and mortality. Additionally, sleep disorders are related to an increased incidence of delirium in Intensive Care Units (ICUs). Routines to control environmental factors in ICUs seem to have an impact on reducing the incidence of acute brain dysfunction - delirium - and could help prevent sleep disturbances in critically ill patients. This study aims to demonstrate an improvement in sleep quality in critically ill patients through the reduction of the Richards-Campbell Sleep Questionnaire score and propose a package of measures to improve sleep practices in ICU-admitted patients.

Conditions

Sleep Disorders

Keywords

Sleep; ICU; Delirium; Multidisciplinary Team; Sleep Protocol

Outcome Measures

Primary Outcomes (1)

• Change in the Richards-Campbell Sleep Quality Score

  To demonstrate a better sleep quality in critical patients

  before and one month after implementation of the sleep protocol

Secondary Outcomes (6)

• Change in the Sleep in the ICU Questionnaire

  before and one month after implementation of the sleep protocol

• Change in the Confusion Assessment Method for the ICU

  before and one month after implementation of the sleep protocol

• Change in the Questionnaire on the patient's perception of sleep from the family member's point of view

  before and one month after implementation of the sleep protocol

• Change in the Questionnaire for the evaluation of the multidisciplinary team regarding prior knowledge of sleep protocol

  before implementation of the sleep protocol

• Change in the Questionnaire for assessing and perceiving patients' sleep from the point of view of the care team

  one month after implementation of the sleep protocol

Study Arms (2)

Pre-sleep protocol group

Patients with inclusion criteria assessed before the implementation of the sleep protocol.

Post-sleep protocol group

Patients with inclusion criteria after the implementation of the sleep protocol.

Behavioral: ICU sleep protocol

Interventions

ICU sleep protocol BEHAVIORAL

Adjusting sound intensity, as well as reducing noise: efforts will be made to minimize staff conversation volume during the night. Earplugs will be offered, along with the provision of eye masks for lucid patients, and thermal comfort adjustments will be made, such as providing blankets and/or adjusting room temperature. Dimming of lights starting from 10 PM. Reduced circulation of external services between 11 PM and 6 AM, and rationalization of sample collections and/or patient transfers between beds during the 11 PM to 6 AM interval. Optimization of analgesics for better pain control; optimization of medication use during wakefulness when clinically feasible; adjustment of intervals for capillary blood glucose measurement; maintaining and/or resuming the use of chronic sleep medications. If the patient has been unable to sleep, a hypnotic medication will be offered. Other considerations include suggesting ventilatory support measures for selected patients.

Post-sleep protocol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the intensive care unit with a minimum stay of two nights

You may qualify if:

• Adult patients (18 years or older);
• Have spent at least two nights in the ICU;
• Neuropsychiatric conditions to respond to the sleep questionnaire Informed consent - authorization through the ICF (Informed Consent Form).

You may not qualify if:

• Neuropsychiatric conditions that prevent responding to the questionnaire, such as patients with dementia, severe sequelae of cerebrovascular disease, inability to understand and/or communicate, severe encephalopathy, deep sedation, acute brain dysfunction and/or delirium, visual and/or auditory acuity impairments that prevent responding to the questionnaire, active alcoholism, active illicit drug use, severe withdrawal symptoms;
• Patients with deep sedation that does not allow interaction with the evaluator;
• Moribund patients;
• Refusal to participate in the study.

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead

Study Sites (2)

Unimed Vale dos Sinos Hospital

Novo Hamburgo, Rio Grande do Sul, Brazil

RECRUITING

Moinhos de Vento Hospital

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Related Publications (8)

• Altman MT, Knauert MP, Pisani MA. Sleep Disturbance after Hospitalization and Critical Illness: A Systematic Review. Ann Am Thorac Soc. 2017 Sep;14(9):1457-1468. doi: 10.1513/AnnalsATS.201702-148SR.

  PMID: 28644698 BACKGROUND

• Beltrami FG, John AB, de Macedo BR, Correa Junior V, Nguyen XL, Pichereau C, Maury E, Fleury B, Gus M, Fagondes SC. A multi-intervention protocol to improve sleep quality in a coronary care unit. Eur J Cardiovasc Nurs. 2022 Jun 30;21(5):464-472. doi: 10.1093/eurjcn/zvab099.

  PMID: 34935040 BACKGROUND

• Ritmala-Castren M, Virtanen I, Vahlberg T, Leivo S, Kaukonen KM, Leino-Kilpi H. Evaluation of patients' sleep by nurses in an ICU. J Clin Nurs. 2016 Jun;25(11-12):1606-13. doi: 10.1111/jocn.13148. Epub 2016 Mar 18.

  PMID: 26991592 BACKGROUND

• Ebben MR, Spielman AJ. Non-pharmacological treatments for insomnia. J Behav Med. 2009 Jun;32(3):244-54. doi: 10.1007/s10865-008-9198-8. Epub 2009 Jan 24.

  PMID: 19169804 BACKGROUND

• Mori S, Takeda JR, Carrara FS, Cohrs CR, Zanei SS, Whitaker IY. Incidence and factors related to delirium in an intensive care unit. Rev Esc Enferm USP. 2016 Jul-Aug;50(4):587-593. doi: 10.1590/S0080-623420160000500007. English, Portuguese.

  PMID: 27680043 BACKGROUND

• Richards KC, Wang YY, Jun J, Ye L. A Systematic Review of Sleep Measurement in Critically Ill Patients. Front Neurol. 2020 Nov 6;11:542529. doi: 10.3389/fneur.2020.542529. eCollection 2020.

  PMID: 33240191 BACKGROUND

• Telias I, Wilcox ME. Sleep and Circadian Rhythm in Critical Illness. Crit Care. 2019 Mar 9;23(1):82. doi: 10.1186/s13054-019-2366-0.

  PMID: 30850003 BACKGROUND

• Li SY, Wang TJ, Vivienne Wu SF, Liang SY, Tung HH. Efficacy of controlling night-time noise and activities to improve patients' sleep quality in a surgical intensive care unit. J Clin Nurs. 2011 Feb;20(3-4):396-407. doi: 10.1111/j.1365-2702.2010.03507.x.

  PMID: 21219521 RESULT

Related Links

• SPIRIT 2013 Checklist

MeSH Terms

Conditions

Sleep Wake Disorders; Delirium

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders

Study Officials

• Laura Drehmer

  Vale dos Sinos Hospital

  PRINCIPAL INVESTIGATOR

• Felippe Dexheimer

  Moinhos de Vento Hospital

  STUDY DIRECTOR

• Cassiano Teixeira

  Moinhos de Vento Hospital

  STUDY DIRECTOR

Central Study Contacts

Laura Drehmer

CONTACT

5551999886722; laura.drehmer@gmail.com

Felippe Dexheimer

CONTACT

555191195508

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 18, 2023
• Study Start: March 20, 2023
• Primary Completion: November 30, 2023
• Study Completion: June 1, 2024
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)