Respiratory RateNCT03750344
ChroniSense Polso Wrist Worn Respiration Rate Validation Study
A study testing Diagnostic test in people with Respiratory Rate, run by ChroniSense Medical Ltd. at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Rate
- What is being tested?
- Diagnostic test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2018to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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,
Show all 34Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Diagnostic test
- Keywords
- Respiratory Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testDevice
Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed
| Study group | Role | What they receive |
|---|---|---|
| ChroniSense Polso Respiratory Rate | Experimental | Not described Receives: Device: Diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, 1 month average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start6 Nov 2018
- Primary completion9 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChroniSense Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur D Cabrera, MD, Study director, Avista Adventist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750344
- Sponsor's protocol ID
- PR 2018-305
- Status last verified
- Nov 2018
- First submitted
- 18 Nov 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ChroniSense Polso Wrist Worn Respiration Rate Validation Study
- ClinicalTrials.gov ID
- NCT03750344
- Acronym / sponsor ID
- PR 2018-305
- Conditions
- Respiratory Rate
- Keywords
- Respiratory Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ChroniSense Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ChroniSense Polso Respiratory Rate | Experimental | Device: Diagnostic test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (34 listed)
- 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:
- Subjects with self-reported heart or cardiovascular conditions such as:
- Self-reported health conditions as identified in the Health Assessment Form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic testComparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed | Device | ChroniSense Polso Respiratory Rate |
Primary outcome
Respiratory Rate Accuracy of Polso Monitoring System
Time frame: Through study completion, 1 month average
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Respiratory Rate
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
Nasal Airway Obstruction
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur D Cabrera, MD study director
Avista Adventist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test in people with Respiratory Rate, run by ChroniSense Medical Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate Accuracy of Polso Monitoring System (time frame: Through study completion, 1 month average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.