Usefulness of vital information by sheet-shaped sensors

JRCT ID: jRCTs042210095

Registered date:02/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cardiovascular diseases
• Date of first enrollment: 09/12/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): A sheet-type contactless sensor will be installed directly under the bed mattress in the hospital room, and the device will record the respiratory rate, pulse rate, and related indicators calculated automatically for up to 3 days.

Outcome(s)

• Primary Outcome: 95% confidence interval of the difference between pulse rates obtained from sheet-shaped contactless sensors and pulse rates measured by blood pressure monitors

Secondary Outcome

95% confidence interval of the difference between respiratory rates obtained from sheet-shaped contactless sensors and respiratory rates counted manually
95% confidence interval of the difference between pulse rates obtained from sheet-shaped contactless sensors and pulse rates obtained from holter electrocardiograms
95% confidence interval of the difference between Yuragi Index obtained from sheet-shaped contactless sensors and indices of detrended fluctuated analysis calculated from holter electrocardiograms

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Stable general condition enough to provide rehabilitation
Ability to lie on his or her back on the bed
Consent to participate in the study

Exclude criteria

-Unable to understand the contents due to cognitive decline (MMSE<15)
-Medical needs for reclining sitting position due to severe heart failure, or unable to keep supine position due to spine kyphosis or pressure ulcers
-High risk for falls or damage of sensors and devices due to severe cognitive dysfunctions
-Unable to obtain the required measures due to severe arrhythmia

Related Information

• Primary Sponsor: Kondo Izumi
• Source(s) of Monetary Support: Techno Horizon Co., Ltd.