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

C

CardiacSense

Status

Unknown

Conditions

Respiratory Disease

Treatments

Device: CardiacSense1 and capnograph Respiratory rate measurement

Study type

Interventional

Funder types

Industry

Identifiers

NCT04580615
CL00450

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Inpatients subjects
Experimental group
Description:
Inpatients subjects diagnosed with a Respiratory disease/impairment or subjects with no known Respiratory disease/impairment
Treatment:
Device: CardiacSense1 and capnograph Respiratory rate measurement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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