Assessment of Sleep Quality of Hospitalized Patients Treated With EEG-guided Protection Procedures: Application in Intensive Care Unit
- Conditions
- Intensive Care UnitCritically Ill PatientSleep Quality
- Interventions
- Other: Control conditionDevice: EEG-guided sleep protection
- Registration Number
- NCT05963672
- Lead Sponsor
- Poitiers University Hospital
- Brief Summary
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")
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
-
Adults admitted in medical ICU of University Hospital of Poitiers
- Un-sedated patients displaying a RASS scale between -2 and +1
- Intubated or spontaneously breathing patients
- Patient or family have signed the inform consent
- Patients with a central nervous system disease altering sleep scoring
- Patients who received drugs (<24h) modifying significantly EEG and sleep scoring
- Patients with cutaneous erosion of the scalp
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Usual Care Control condition - EEG-guided sleep protection EEG-guided sleep protection -
- Primary Outcome Measures
Name Time Method Sleep quality Day 1 to Day 4 Proportion of continuous sleep
- Secondary Outcome Measures
Name Time Method Sleep fragmentation Day 1 to Day 4 Number of awakenings and micro-awakenings per hour of sleep
Environmental noise and environmental light Day 1 to Day 4 Number of peak noise end time spent above 20 lux
Sleep interruptions by caregivers Day 1 to Day 4 Number of room entries while patient is asleep
Sleep quality Day 2 to Day 4 Proportion of continuous sleep
Workload assessed by nurses Day 1 to Day 4 Score at specific scale assessing workload. From 1- no workload to 10- significant additional workload.
Patient Agitation Day 1 to day 4 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)
Performance of the algorithm Day 1 to Day 4 Number of sleep episodes lasting more than 10 min correctly identified by algorithm (versus vision scoring)
Patient reported sleep quality Day 1 to day 4 Score et richards-Campbell sleep questionnaire. It consist of 6 questions, each question scored from 0 to 100. Higher score mean the better sleep
Anxiety level Day 1 to day 4 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.
Respiratory status At Unit care discharge, an average of 14 days Weaning duration (number of days), ventilator free days and respiratory status at discharge
Presence of delirium Day 1 to Day 4 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.
Unit Care length of stay At Unit care discharge, an average of 14 days Number of days in ICU
Safety of the procedure One day after Unit Care discharge, an average of 15 days Numbers of Serious adverse events and Material defect events
Sleep continuity Day 1 to Day 4 Part of sleep time past in more than 10 minutes episodes
Trial Locations
- Locations (1)
CHU Poitiers
🇫🇷Poitiers, France