Protocol For Sleep for Critically Ill Patients

August 9, 2023 updated by: Laura Drehmer, Hospital Moinhos de Vento

Multidisciplinary Protocol for Best Pracrice in Sleep for Critically Ill Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Felippe Dexheimer
  • Phone Number: 555191195508

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Novo Hamburgo, Rio Grande Do Sul, Brazil
        • Recruiting
        • Unimed Vale dos Sinos Hospital
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Recruiting
        • Moinhos de Vento Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Richards-Campbell Sleep Quality Score
Time Frame: before and one month after implementation of the sleep protocol
To demonstrate a better sleep quality in critical patients
before and one month after implementation of the sleep protocol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Sleep in the ICU Questionnaire
Time Frame: before and one month after implementation of the sleep protocol
Characterization of the perception of factors influencing sleep in critically ill patients
before and one month after implementation of the sleep protocol
Change in the Confusion Assessment Method for the ICU
Time Frame: before and one month after implementation of the sleep protocol
To evaluate the incidence of delirium and its duration according to sleep quality;
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
Time Frame: before and one month after implementation of the sleep protocol
To compare patient satisfaction at ICU discharge with family satisfaction
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
Time Frame: before implementation of the 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
Change in the Questionnaire for assessing and perceiving patients' sleep from the point of view of the care team
Time Frame: one month after implementation of the sleep protocol
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
Change in the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale.
Time Frame: at three and six months after hospital discharge
To evaluate the sleep quality of surviving patients of critical illnesses at ICU discharge
at three and six months after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Moinhos de Vento

Investigators

  • Principal Investigator: Laura Drehmer, Vale dos Sinos Hospital
  • Study Director: Felippe Dexheimer, Moinhos de Vento Hospital
  • Study Director: Cassiano Teixeira, Moinhos de Vento Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

July 10, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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