MedPath

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

Not Applicable
Conditions
Respiratory Disease
Registration Number
NCT04580615
Lead Sponsor
CardiacSense Ltd.
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
30
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Respiratory rate24 hours

Capnograph and Cardiacsense1 sensor Respiratory rate

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center

🇮🇱

Tel Aviv, Israel

Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.