Respiratory RateNCT05246358
Respiratory Rate Validation Study - ChroniSense Polso
A study testing ChoniSense Polso in people with Respiratory Rate, run by ChroniSense Medical Ltd. at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 52 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Rate
- What is being tested?
- ChoniSense Polso
- 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
- 10 May 2021to 11 Jun 2021
- 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 to 52 years
- All sexes
- Healthy volunteers accepted
- 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, or a smoker who has refrained from smoking for 1 day.
- Male or female of any race
Who cannot join
- 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,
Show all 33Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinimark Desaturation Laboratory, Site ID# 001
Louisville, Colorado, 80027
About this study
20 volunteer test subjects entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso
Read the 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.
- Conditions
- Respiratory Rate
- Being tested
- ChoniSense Polso
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChoniSense PolsoDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ChroniSense Polso Respiratory Rate | Experimental | Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed Receives: Device: ChoniSense Polso |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted18 Feb 2022
- Study start10 May 2021
- Primary completion14 May 2021
- Study completion11 Jun 2021
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246358
- Sponsor's protocol ID
- PR 2020-414
- Status last verified
- Feb 2022
- First submitted
- 23 Jan 2022
- Last updated
- 18 Feb 2022
- 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 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Rate Validation Study - ChroniSense Polso
- ClinicalTrials.gov ID
- NCT05246358
- Acronym / sponsor ID
- PR 2020-414
- Conditions
- Respiratory Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ChroniSense Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 18 Feb 2022 (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 entered into an accuracy study that is designed to validate accuracy of the respiratory rate of the ChroniSense Polso
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 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: ChoniSense PolsoComparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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, or a smoker who has refrained from smoking for 1 day.
- Male or female of any race
Key exclusion criteria (33 listed)
- 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:
- Subjects with self-reported heart or cardiovascular conditions such as:
- Self-reported health conditions as identified in the Health Assessment Form
- Other known health condition, should be considered upon disclosure in 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 |
|---|---|---|
| ChoniSense PolsoA 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. | Device | ChroniSense Polso Respiratory Rate |
Primary outcome
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.
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 18 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ChoniSense Polso 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 5 inclusion and 33 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 18 Feb 2022. 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?
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). 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 18 Feb 2022.