Anonymized Data Collection From the CardiacSense1 and Other Modalities for the Purpose of Developing a System for Monitoring of Respiratory Rate
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- CardiacSense Ltd.
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Respiratory rate
Study Overview
Brief Summary
Collect data from the CardiacSense1's sensors and Capnograph, for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) in patients while at hospital
Detailed Description
Hospitalized subjects, diagnosed with a Respiratory disease or subjects with no known Respiratory disease will be will be connected simultaneously to CardiacSense watch and Capnograph for a duration of at least 30 minutes and up to 24 hours in order to collect data for the purpose of developing a wearable system for monitoring of Respiratory Rate (RR) by the CardiacSense watch.
The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation. CardiacSense1 senses the radial artery inflation and deflation and together with a PPG sensors give an ultimate performance that is superior to PPG only.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age of eighteen (18) year and above
- •Diagnosed with Respiratory disease/impairment or without any known Respiratory disease/impairment
- •Ability and willingness to sign an informed consent form
Exclusion Criteria
- •Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
- •Patients with significant co morbidities (assessed by the clinician at screening only
- •Presence of an acute disease process that might interfere with test performance
- •Subjects with PPG SNR <100 indicated by the CardiacSense1 device
- •Women who are pregnant or breastfeeding
Outcomes
Primary Outcomes
Respiratory rate
Time Frame: 24 hours
Capnograph and Cardiacsense1 sensor Respiratory rate
Secondary Outcomes
No secondary outcomes reported