Continuous monitoring of analgesia and sedation using wearable device with motion sensors in a pediatric intensive care unit
Not Applicable
- Conditions
- Childern in a pediatric intensive care unit
- Registration Number
- JPRN-UMIN000046203
- Lead Sponsor
- Osaka Women's and Children's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
Exclude patients on muscle relaxants, with tetraplegia, with restrainer, with severe contractures, and with difficulty in wearing a wearable device, who have difficulty in assessing body movements. Patients with severe mental retardation who are difficult to assess for analgesia and sedation by SBS/RASS should also be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1)Correlation between body motion data such as frequency, duration, and intensity of body movements assessed by accelerometers and the SBS/RASS analgesic sedation scale assessed by observers.
- Secondary Outcome Measures
Name Time Method (2) The incidence of discomfort, restlessness, or inability to continue wearing the wearable device, and the adverse events such as dermatitis. (3) Association between the patient's restlessness, dangerous behaviors, and asynchronization with the mechanical ventilation observed by medical staff and inappropriate sedation state based on body motion data. (4) Correlation between analgesic sedation evaluation using SBS/RASS analgesic sedation scale and body motion data with image information such as eye opening and crying.