ChroniSense Polso Wrist Worn Respiration Rate Validation Study

Respiratory Rate Clinical Trial

Official title:

ChroniSense Polso Wrist Worn Respiration Rate Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750344
• Other study ID #: PR 2018-305
• Status: Completed
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: November 2018
• Source: ChroniSense Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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

• 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

Related Conditions & MeSH terms

• Respiratory Rate

Intervention

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

Locations

Country	Name	City	State
United States	Clinimark	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	Respiratory Rate Accuracy of Polso Monitoring System	Respiratory Rate of test subject as compared to CO2 of End Tidal Carbon. Twenty second periods will be averaged to provide one respiratory rate value. Each stable respiratory rate plateau will result in four of these respiratory rate values which will be included in the ARMS calculation. The endpoint of interest is accuracy as measured by the Accuracy root-mean-square (Arms) difference between the device under test (DUT) and the reference respiratory rate system (Ref) for all stable respiratory periods. Acceptance criteria ARMS <3	Through study completion, 1 month average