Sleep of critically ill patients is highly disturbed with a high sleep fragmentation; patients spend most of their sleep in very short sleep episodes, lasting less than 10 minutes. Causes of theses sleep alterations are complex including environmental noise (alarms, beepers, conversations…), continuous light, nurse care and repetitive measures of vital parameters. Numerous studies have reported a relationship between severe sleep alterations and a prolonged weaning period and mortality. Improving sleep quality in critically ill patients is a major challenge to promote ICU patient's recovery. A very promising treatment is the application of a nocturnal " quiet-time " during which non urgent care, comfort care, systematic measures of vital parameters are delayed and clustered in order to limit room entries. However, " quiet time " procedures have failed to improve sleep quality to date. A miniaturized medical device recording one EEG channel and embedding an automated sleep scoring algorithm running in real-time was devised. This device (positioned on forehead, and continuously recording noise and light levels) indicates if the patient is awake or asleep using a tablet positioned at doorstep of the room, so that nurses know if patient is sleeping, without entering the room. Hypothesis proposes that applying sleep protection procedures (clustering cares, limiting room entries, reducing lights and noise, delaying non urgent care…) when patients are sleeping (= EEG-guided strategies) will increase patients sleep quality. This study will assess the effect of such device on sleep quality in ICU patients. This is a "before / after" design. The first group ("control group"), will be recorded but the sleep scoring will not be displayed by the tablet and patient will be expose to standard care. Then, procedure will be established collegially with nurses, nurses assistants and doctors. Then, the second group ("treated group") will be recorded with the device displaying the status of the patient (asleep/awake) and all caregivers will be asked to follow the established rules ("EEG-guided sleep protection rules")
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
The tablet will display a specific picture "prioritize sleep" or "prioritize care" depending on the patient status determined by the algorithm. When the picture "favor/prioritize sleep" is displayed, all caregivers and visiting family are asked to follow the sleep protection rules: refrain to enter the room for not urgent reasons, switch off television, reduced light in the room/corridor, reduce noise in front of the door, close curtain (if any), and delay non urgent care…etc; if caregivers have to enter the room, headlight and/or additional light will be favored. All these rules will be established collegially by nurses and doctors. Obviously, urgent care and reactions to alarms are maintained. When the picture "favor/prioritize care" is displayed, all caregivers and visiting family are invited to perform non urgent care, cleaning, restocking perfusion needles, comfort care, visiting.
the recording device will be placed on the patient to record sleep but the tablet will be masked and placed face down on the bench in the room, invisible from the door.
CHU Poitiers
Poitiers, France
Sleep quality
Proportion of continuous sleep
Time frame: Day 1 to Day 4
Sleep fragmentation
Number of awakenings and micro-awakenings per hour of sleep
Time frame: Day 1 to Day 4
Environmental noise and environmental light
Number of peak noise end time spent above 20 lux
Time frame: Day 1 to Day 4
Sleep interruptions by caregivers
Number of room entries while patient is asleep
Time frame: Day 1 to Day 4
Sleep quality
Proportion of continuous sleep
Time frame: Day 2 to Day 4
Workload assessed by nurses
Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload.
Time frame: Day 1 to Day 4
Patient Agitation
Number of patients with diminishing (-1 point) Richmond Agitation-Sedation Scale (RASS) score. 10 Agitation-Sedation scale items From +4 (combative) to -5 (non-recoverable)
Time frame: Day 1 to day 4
Performance of the algorithm
Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring)
Time frame: Day 1 to Day 4
Patient reported sleep quality
Score et richards-Campbell sleep questionnaire. It consist of 6 questions, each question scored from 0 to 100. Higher score mean the better sleep
Time frame: Day 1 to day 4
Anxiety level
Score at Spielberger Y-A scale.It consist of 12 questions, each rated on a scale with 4 response options. Lower score means a minimal anxiety level.
Time frame: Day 1 to day 4
Respiratory status
Weaning duration (number of days), ventilator free days and respiratory status at discharge
Time frame: At Unit care discharge, an average of 14 days
Presence of delirium
Number of days with positive Confusion Assessment Method(CAM)-ICU scale. It is made up of 4 criteria. The test is POSITIVE (confusion present) if 1 and 2 + 3 or 4 are met.
Time frame: Day 1 to Day 4
Unit Care length of stay
Number of days in ICU
Time frame: At Unit care discharge, an average of 14 days
Safety of the procedure
Numbers of Serious adverse events and Material defect events
Time frame: One day after Unit Care discharge, an average of 15 days
Sleep continuity
Part of sleep time past in more than 10 minutes episodes
Time frame: Day 1 to Day 4
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