- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05246358
Respiratory Rate Validation Study - ChroniSense Polso
Study Overview
Detailed Description
20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso.
A range of stable respiratory rates were elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers.
Each subject was instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor was used as the Accuracy Reference Device (Reference) in this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
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Louisville, Colorado, United States, 80027
- Clinimark Desaturation Laboratory, Site ID# 001
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject must have the ability to understand and provide written informed consent
- Subject is adult over 18 years of age
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker, or a smoker who has refrained from smoking for 1 day.
- Male or female of any race
Exclusion Criteria:
Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoo in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
Subjects with known respiratory conditions such as:
- uncontrolled / severe asthma,
- flu,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- respiratory or lung surgery,
- emphysema, COPD, lung disease
Subjects with self-reported heart or cardiovascular conditions such as:
- high blood pressure: systolic >140 mmHg or diastolic >90 mmHg
- have had cardiovascular surgery
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
Self-reported health conditions as identified in the Health Assessment Form
- diabetes,
- uncontrolled thyroid disease, kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- epilepsy,
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent head injury within the last 2 months,
- Cancer / chemotherapy
- Other known health condition, should be considered upon disclosure in health assessment form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ChroniSense Polso Respiratory Rate
Comparison of respiratory rates in normal subjects as observational with end tidal CO2.
No treatment or interventions will be performed
|
A range of stable respiratory rates was elicited from each volunteer test subject. The rates were 5, 10, 15, 20, 25, 30, 35, 40 and 45 breaths per minute; with some natural variation from these exact numbers. Each subject was instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor was used as the Accuracy Reference Device (Reference) in this study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arms accuracy (breaths per minute) of Polso Monitoring System relative to End Tidal Carbon Dioxide monitor-derived respiration rate
Time Frame: Through study completion, 1 month average
|
Accuracy of Polso Monitoring System (DUT) relative to a reference End Tidal Carbon Dioxide monitor-derived respiration rate (REF).
Polso reports respiration rate (breaths per minute) directly, at 60 second intervals.
End Tidal Carbon Dioxide monitor waveforms will be hand-scored, based on respiration waveform peaks, to derive respiration rate (breaths per minute).
The readings from each device will be synchronized to achieve paired simultaneous respiration rates, and aggregated into calculation of a comparative accuracy measure, namely Accuracy root-mean-square (Arms) difference, in breaths per minute, between the Polso (DUT) and the reference (REF) respiratory rate system, for all stable respiratory periods.
Acceptance criteria Arms <3.
|
Through study completion, 1 month average
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PR 2020-414
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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