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

NCT04580615 | Unknown

• 1 other identifier: CL00450
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Disease

Keywords

Respiratory rate

Outcome Measures

Primary Outcomes (1)

• Respiratory rate

  Capnograph and Cardiacsense1 sensor Respiratory rate

  24 hours

Study Arms (1)

Inpatients subjects

EXPERIMENTAL

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

Device: CardiacSense1 and capnograph Respiratory rate measurement

Interventions

CardiacSense1 and capnograph Respiratory rate measurement 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.

Inpatients subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 62431, Israel

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Giris Jacob, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: October 8, 2020
• Study Start: June 3, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)