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

Respiratory Disease Clinical Trial

— RRP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04580615
• Other study ID #: CL00450
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: January 2022
• Source: CardiacSense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
CardiacSense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate	Capnograph and Cardiacsense1 sensor Respiratory rate	24 hours