Respiratory Rate Validation Study - ChroniSense Polso

Respiratory Rate Clinical Trial

Official title:

Respiratory Rate Validation Study - ChroniSense Polso

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246358
• Other study ID #: PR 2020-414
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: June 11, 2021

Study information

• Verified date: February 2022
• Source: ChroniSense Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 11, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Rate

Intervention

Device:
• ChoniSense Polso
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.

Locations

Country	Name	City	State
United States	Clinimark Desaturation Laboratory, Site ID# 001	Louisville	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
ChroniSense Medical Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arms accuracy (breaths per minute) of Polso Monitoring System relative to End Tidal Carbon Dioxide monitor-derived respiration rate	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