Clinical trial NCT05996861: Protocol For Sleep for Critically Ill Patients
Official title: Multidisciplinary Protocol for Best Pracrice in Sleep for Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Disorders
Keywords: Sleep
ICU
Delirium
Multidisciplinary Team
Sleep Protocol
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the intensive care unit with a minimum stay of two nights

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Richards-Campbell Sleep Quality Score
timeFrame: before and one month after implementation of the sleep protocol
Secondary outcomes:
measure: Change in the Sleep in the ICU Questionnaire
timeFrame: before and one month after implementation of the sleep protocol
measure: Change in the Confusion Assessment Method for the ICU
timeFrame: before and one month after implementation of the sleep protocol
measure: Change in the Questionnaire on the patient's perception of sleep from the family member's point of view
timeFrame: before and one month after implementation of the sleep protocol
measure: Change in the Questionnaire for the evaluation of the multidisciplinary team regarding prior knowledge of sleep protocol
timeFrame: before implementation of the sleep protocol
measure: Change in the Questionnaire for assessing and perceiving patients' sleep from the point of view of the care team
timeFrame: one month after implementation of the sleep protocol
measure: Change in the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale.
timeFrame: at three and six months after hospital discharge
Other outcomes:
Locations:
city: Novo Hamburgo
country: Brazil
facility: Unimed Vale dos Sinos Hospital
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Moinhos de Vento Hospital
state: Rio Grande Do Sul
Study officials:
affiliation: Vale dos Sinos Hospital
name: Laura Drehmer
role: PRINCIPAL_INVESTIGATOR
affiliation: Moinhos de Vento Hospital
name: Felippe Dexheimer
role: STUDY_DIRECTOR
affiliation: Moinhos de Vento Hospital
name: Cassiano Teixeira
role: STUDY_DIRECTOR
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