Protocol For Sleep for Critically Ill Patients

Sleep Disorders Clinical Trial

Official title:

Multidisciplinary Protocol for Best Pracrice in Sleep for Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996861
• Other study ID #: 842
• Status: Recruiting
• Start date: March 20, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Hospital Moinhos de Vento
• Contact: Laura Drehmer
• Phone: 5551999886722
• Email: laura.drehmer[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Detailed description:

Critically ill patients are particularly vulnerable to sleep disorders. In the context of critical illness and ICU admission, there is an intersection of factors contributing to this situation: pre-existing health conditions, severe acute illness, sleep-altering treatments (sedatives, analgesics, mechanical ventilation), psychiatric disorders, and the physical environment. In addition to the impact during hospitalization, the literature points to a long-term reduction in quality of life due to sleep disturbance. Recent studies following up on patients after ICU discharge reveal high rates of sleep disorders up to 6 months after hospital discharge - related or unrelated to new psychiatric disorders and even cognitive changes. Furthermore, sleep disorders are associated with an increased incidence of delirium in ICUs, which refers to altered consciousness and cognition in patients admitted to the intensive care environment, which are associated with worsened patient outcomes such as increased hospital stay and consequently the risk of fatal complications. The prevalence of delirium is around 70%, with an incidence of 89%. Delirium assessment in ICUs is usually performed daily.

In order to improve the sleep quality of this population, there are modifiable factors, whether environmental (lighting, noise, general care), physiological (medications, ventilatory parameter adjustments), or psychological (anxiety, pain, absence of family members). 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. These measures include dimming or reducing corridor lights at night, grouping (when possible) care activities at appropriate times, raising curtains, and encouraging mobilization during daytime shifts. For non-delirious patients, the use of earplugs and eye masks is also recommended.

Therefore, the investigators have developed this research project with the aim of evaluating the implementation of a multifaceted and multidisciplinary protocol to promote an improvement in sleep quality in critically ill patients.

The SPIRIT Protocol is a summary of recommendations for clinical trials, which was used as a support in this study. This is a multicenter clinical trial with a quasi-experimental design.

The first step consists of assessing the sleep quality in sequential patients admitted to the ICU and characterizing the disruptive elements.

After this period, the second step will involve sensitizing and training the multidisciplinary team about the importance of sleep for critically ill patients and providing training for the implementation of a multifaceted protocol of interventions to promote sleep quality improvement.

Once the multidisciplinary protocol is implemented, the sleep quality of the patients and the clinical impact of this protocol will be reevaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Sleep Disorders
• Sleep Wake Disorders

Intervention

Behavioral:
• ICU sleep protocol
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.

Locations

Country	Name	City	State
Brazil	Unimed Vale dos Sinos Hospital	Novo Hamburgo	Rio Grande Do Sul
Brazil	Moinhos de Vento Hospital	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the Sleep in the ICU Questionnaire	Characterization of the perception of factors influencing sleep in critically ill patients	before and one month after implementation of the sleep protocol
Secondary	Change in the Confusion Assessment Method for the ICU	To evaluate the incidence of delirium and its duration according to sleep quality;	before and one month after implementation of the sleep protocol
Secondary	Change in the Questionnaire on the patient's perception of sleep from the family member's point of view	To compare patient satisfaction at ICU discharge with family satisfaction	before and one month after implementation of the sleep protocol
Secondary	Change in the Questionnaire for the evaluation of the multidisciplinary team regarding prior knowledge of sleep protocol	To assess the knowledge of the multidisciplinary team regarding sleep in critically ill patients before the implementation of the multidisciplinary protocol	before implementation of the sleep protocol
Secondary	Change in the Questionnaire for assessing and perceiving patients' sleep from the point of view of the care team	To assess the perception of the multidisciplinary team regarding the sleep quality of hospitalized patients after the implementation of the multidisciplinary protocol	one month after implementation of the sleep protocol
Secondary	Change in the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale.	To evaluate the sleep quality of surviving patients of critical illnesses at ICU discharge	at three and six months after hospital discharge

External Links

•   SPIRIT 2013 Checklist