Data Collection From the CardiacSense1 and Other Modalities for Developing a System for Monitoring of Respiratory Rate

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anonymized Data Collection From the CardiacSense1 and Other Modalities for the Purpose of Developing a System for Monitoring of Respiratory Rate

Conditions
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Respiratory Disease

Intervention / Treatment
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* Device: CardiacSense1 and capnograph Respiratory rate measurement


Participation Criteria
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Eligibility Criteria
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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 BMI>40 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inpatients subjects<br>Inpatients subjects diagnosed with a Respiratory disease/impairment or subjects with no known Respiratory disease/impairment | Device: CardiacSense1 and capnograph Respiratory rate measurement<br>* Inpatients Subjects with respiratory disease/impairment and Inpatients Subjects with no known respiratory disease/impairment will be measured simultaneously with both CardiacSense1 and capnograph for at least 30 minutes up to 24 hours. During this time capnograph data will be recorded in parallel to CardiacSense1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory rate | Capnograph and Cardiacsense1 sensor Respiratory rate | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory rate