Back to resultsData Collection From the CardiacSense1 and Other Modalities for Developing a System for Monitoring of Respiratory Rate (RRP)
Primary Purpose
Respiratory Disease
Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CardiacSense1 and capnograph Respiratory rate measurement
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Disease focused on measuring Respiratory rate
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
Sites / Locations
- Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Inpatients subjects
Arm Description
Inpatients subjects diagnosed with a Respiratory disease/impairment or subjects with no known Respiratory disease/impairment
Outcomes
Primary Outcome Measures
Respiratory rate
Capnograph and Cardiacsense1 sensor Respiratory rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04580615
Brief Title
Data Collection From the CardiacSense1 and Other Modalities for Developing a System for Monitoring of Respiratory Rate
Acronym
RRP
Official Title
Anonymized Data Collection From the CardiacSense1 and Other Modalities for the Purpose of Developing a System for Monitoring of Respiratory Rate
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardiacSense Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease
Keywords
Respiratory rate
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inpatients subjects
Arm Type
Experimental
Arm Description
Inpatients subjects diagnosed with a Respiratory disease/impairment or subjects with no known Respiratory disease/impairment
Intervention Type
Device
Intervention Name(s)
CardiacSense1 and capnograph Respiratory rate measurement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Respiratory rate
Description
Capnograph and Cardiacsense1 sensor Respiratory rate
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giris Jacob, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
62431
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD to be shared with other researcher
Learn more about this trial
Data Collection From the CardiacSense1 and Other Modalities for Developing a System for Monitoring of Respiratory Rate
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