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

Not Applicable

• Conditions: Respiratory Disease
• Interventions: Device: CardiacSense1 and capnograph Respiratory rate measurement

• 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.

Study Timeline

• Study First Submitted: 2020-04-16
• Study Start: 2020-06-03
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01

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

Arm && Interventions

Group	Intervention	Description
Inpatients subjects	CardiacSense1 and capnograph Respiratory rate measurement	Inpatients subjects diagnosed with a Respiratory disease/impairment or subjects with no known Respiratory disease/impairment

Primary Outcome Measures

Name	Time	Method
Respiratory rate	24 hours	Capnograph and Cardiacsense1 sensor Respiratory rate

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel