Ignite Creation Date:
2025-12-24 @ 12:50 PM
Ignite Modification Date:
2025-12-29 @ 2:00 AM
Study NCT ID:
NCT05996861
Status:
UNKNOWN
Last Update Posted:
2023-08-18
First Post:
2023-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol For Sleep for Critically Ill Patients
Sponsor:
Hospital Moinhos de Vento
Organization:
Study Overview
Official Title:
Multidisciplinary Protocol for Best Pracrice in Sleep for Critically Ill Patients
Status:
UNKNOWN
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: