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

NCT ID: NCT04580615

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2022-05-01

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.

Conditions

Respiratory Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Inpatients subjects

Inpatients subjects diagnosed with a Respiratory disease/impairment or subjects with no known Respiratory disease/impairment

Group Type: EXPERIMENTAL

CardiacSense1 and capnograph Respiratory rate measurement

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CardiacSense Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giris Jacob, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

CL00450

Identifier Type: -

Identifier Source: org_study_id