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Clinical Trials/NCT04580615
NCT04580615UnknownNot Applicable

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

CardiacSense Ltd.2 sites in 1 country30 target enrollmentStarted: June 3, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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