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Protocol For Sleep for Critically Ill Patients

Multidisciplinary Protocol for Best Pracrice in Sleep for Critically Ill Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05996861
Enrollment
100
Registered
2023-08-18
Start date
2023-03-20
Completion date
2024-06-01
Last updated
2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders

Keywords

Sleep, ICU, Delirium, Multidisciplinary Team, Sleep Protocol

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.

Detailed 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.

Interventions

BEHAVIORALICU 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.

Sponsors

Hospital Moinhos de Vento
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the Richards-Campbell Sleep Quality Scorebefore and one month after implementation of the sleep protocolTo demonstrate a better sleep quality in critical patients

Secondary

MeasureTime frameDescription
Change in the Confusion Assessment Method for the ICUbefore and one month after implementation of the sleep protocolTo evaluate the incidence of delirium and its duration according to sleep quality;
Change in the Questionnaire on the patient's perception of sleep from the family member's point of viewbefore and one month after implementation of the sleep protocolTo compare patient satisfaction at ICU discharge with family satisfaction
Change in the Sleep in the ICU Questionnairebefore and one month after implementation of the sleep protocolCharacterization of the perception of factors influencing sleep in critically ill patients
Change in the Questionnaire for assessing and perceiving patients' sleep from the point of view of the care teamone month after implementation of the sleep protocolTo assess the perception of the multidisciplinary team regarding the sleep quality of hospitalized patients after the implementation of the multidisciplinary protocol
Change in the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale.at three and six months after hospital dischargeTo evaluate the sleep quality of surviving patients of critical illnesses at ICU discharge
Change in the Questionnaire for the evaluation of the multidisciplinary team regarding prior knowledge of sleep protocolbefore implementation of the sleep protocolTo assess the knowledge of the multidisciplinary team regarding sleep in critically ill patients before the implementation of the multidisciplinary protocol

Countries

Brazil

Contacts

Primary ContactLaura Drehmer
laura.drehmer@gmail.com5551999886722
Backup ContactFelippe Dexheimer
555191195508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026