ChroniSense Polso Wrist Worn Respiration Rate Validation Study

NCT ID: NCT03750344

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2018-11-30

Brief Summary

20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system

Detailed Description

20 volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the Polso Monitoring system.

A range of stable respiratory rates will be 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 will be 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 will be used as the Accuracy Reference Device (Reference) in this study.

Conditions

Respiratory Rate

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ChroniSense Polso Respiratory Rate

Group Type: EXPERIMENTAL

Diagnostic test

Intervention Type: DEVICE

Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed

Interventions

Diagnostic test

Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed

Intervention Type: DEVICE

Eligibility Criteria

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
• Male or female of any race
• Wrist circumference with the range of 5.5-8 inches (13 to 21cm)

Exclusion Criteria

• Subject is considered as being morbidly obese (defined as BMI >39.5)
• 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.
• 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:

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ChroniSense Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur D Cabrera, MD

Role: STUDY_DIRECTOR

Avista Adventist Hospital

Locations

Clinimark

Louisville, Colorado, United States

Countries

United States

Other Identifiers

PR 2018-305

Identifier Type: -

Identifier Source: org_study_id