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Continuous monitoring of analgesia and sedation using wearable device with motion sensors in a pediatric intensive care unit

Continuous monitoring of analgesia and sedation using wearable device with motion sensors in a pediatric intensive care unit - Continuous monitoring of analgesia and sedation using wearable device with motion sensors in a pediatric intensive care unit

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046203
Enrollment
100
Registered
2021-12-01
Start date
2021-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childern in a pediatric intensive care unit

Interventions

Sponsors

Osaka Women's and Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children in pediatric intensive care unit

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
(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

MeasureTime frame
(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.

Countries

Japan

Contacts

Public ContactTakeshi Hatachi

Osaka Women's and Children's Hospital Department of Intensive Care Medicine

hatachi@mch.pref.osaka.jp0725-56-1220

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026