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NCT04580615 Clinical Trial

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

Respiratory Disease Clinical Trial

— RRP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04580615
Other study ID # CL00450
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 3, 2020
Est. completion date May 1, 2022

Study information
Verified date January 2022
Source CardiacSense Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CardiacSense1 and capnograph Respiratory rate measurement
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.

Locations
Country Name City State
Israel Tel Aviv Sourasky Medical Center Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
CardiacSense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory rate Capnograph and Cardiacsense1 sensor Respiratory rate 24 hours
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