Sleep Bundle for Improving Sleep in ICU Patients

NCT03247062 | Unknown

• 1 other identifier: ICU Sleep - 01
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

Summary of the project : Lack or disturbances of sleep are major problems in patients staying in intensive care unit (ICU) due to the particular environment. The noises, lack of circadian rhythm of light lead to progressive deafferentation. The patients are then at risk of immune deficiencies, agitation and confusion states, cognitive troubles that may be associated to increased morbidity and mortality in the short and long term. Thus, improvement of the sleep of the ICU patients may impact non only during the ICU stay but also on their future quality of life. The sleep bundle project is a quality improvement project with a before-after design, consisting in the evaluation of a bundle of measures that may increase the quality and duration of sleep in ICU patients. The bundle consists in the proposition of eye-mask, ear-plugs, music and/or massage to the patients in parallele to structural and organizational modifications of the service such as the decrease of the alarms sounds, changing the luminosity between day and night, etc. The principal indicators followed will be:

• The sleep quality of the patients
• The continuous noise intensity in the rooms
• The continuous light intensity in the rooms Baseline - before period: 8 weeks Implementation of the bundle with training of the team: 4 weeks After period: 8 weeks.

Conditions

Sleep; Intensive Care Unit Syndrome

Keywords

agitation, sleep deprivation, bundle

Outcome Measures

Primary Outcomes (1)

• Improvement of the quality of sleep in ICU patients measured by the Richards Campbell Sleep Questionnaire (RCSQ)

  Before-after design aiming at increasing the Richards Campbell Sleep Questionnaire (RCSQ) of ICU patients.

  6 months

Secondary Outcomes (3)

• agitation episodes

  6 months

• delirium

  6 months

• patient related incident

  6 months

Study Arms (1)

Cohort study (Before-after desgin)

OTHER

Quality improvement - sleep bundle Intervention consists in a sleep bundle, an aggregate of several propositions to improve the sleep of patients.: implementation of a sleep bundle. The entire ICU population will be observed before and after intervention.

Other: Quality improvement - sleep bundle

Interventions

Quality improvement - sleep bundle OTHER

implementation of a sleep bundle

Also known as: A sleep bundle to improve the sleep of patients.

Cohort study (Before-after desgin)

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 yo),
• Hospitalised for ≥ 24h in ICU
• Planned stay of more than 1 day
• After termination of sedation
• Glasgow ≥ 12, SAS ≥ 3-4, CAM-ICU negative

You may not qualify if:

• patients with neueological disease or neurosurgery requiring neurological assessment every 4hours or more

Sponsors & Collaborators

• University Hospital, Geneva: lead

MeSH Terms

Conditions

Psychomotor Agitation; Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Quality improvement project - before after design

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: August 11, 2017
• Study Start: September 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: August 31, 2018
• Last Updated: August 11, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share