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Clinical Trials/NCT04580615
NCT04580615
Unknown
Not Applicable

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

CardiacSense Ltd.1 site in 1 country30 target enrollmentJune 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Disease
Sponsor
CardiacSense Ltd.
Enrollment
30
Locations
1
Primary Endpoint
Respiratory rate
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 3, 2020
End Date
May 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Study Sites (1)

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