Sleep Bundle for Improving Sleep in ICU Patients
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|ClinicalTrials.gov Identifier: NCT03247062|
Recruitment Status : Unknown
Verified May 2017 by Pr. Bara RICOU, University Hospital, Geneva.
Recruitment status was: Not yet recruiting
First Posted : August 11, 2017
Last Update Posted : August 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Intensive Care Unit Syndrome||Other: Quality improvement - sleep bundle||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Quality improvement project - before after design|
|Masking:||None (Open Label)|
|Official Title:||Improving the Quality of Sleep in ICU Patients With a "Sleep Bundle"|
|Estimated Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||February 28, 2018|
|Estimated Study Completion Date :||August 31, 2018|
Cohort study (Before-after desgin)
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
implementation of a sleep bundle
Other Name: A sleep bundle to improve the sleep of patients.
- Improvement of the quality of sleep in ICU patients measured by the Richards Campbell Sleep Questionnaire (RCSQ) [ Time Frame: 6 months ]Before-after design aiming at increasing the Richards Campbell Sleep Questionnaire (RCSQ) of ICU patients.
- agitation episodes [ Time Frame: 6 months ]SAS > 6
- delirium [ Time Frame: 6 months ]CAM ICU +
- patient related incident [ Time Frame: 6 months ]unvoluntary extubation, cathéters or tube retrieval