Respiratory RateNCT04104737
Spire Medical Health Tag Respiratory Rate Validation in Adults
A study testing Spire Medical Health Tag in people with Respiratory Rate, run by Spire, Inc. at 2 sites in United States.
Trial summary
The primary purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Spire Medical Health Tag to a FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda). 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?
- Spire Medical Health Tag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2019to 13 Jun 2019
- 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
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. (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,
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
2 sites in 1 country.
United States2 sites
Arthur Cabrera, MD.
Louisville, Colorado, 80027
Spire, Inc.
San Francisco, California, 94110
About this study
The primary purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Spire Medical Health Tag to a FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).
After IRB approval, a minimum of 20 healthy volunteer test subjects, 18 or older will be entered into this study designed to validate the accuracy of the respiratory rate feature of the Spire Medical Health Tag (Device Under Test).
Read more
The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMIs. Each subject will be connected to a FDA cleared EtCO2 monitor (GE Datex-Ohmeda) and will be instrumented with a mouthpiece or open system mask that allows for measurement of EtCO2 derived respiratory rate. A range of stable respiratory rates will be elicited from each volunteer test subject with the use of a paced breathing application on a mobile phone. Subjects will also be connected to a 3-lead ECG (GE Datex-Ohmeda) for the purpose of monitoring heart rate and comparing to the pulse rate measurements recorded by the Spire Medical Health Tag.
The respiratory rate and pulse rate will be measured simultaneously for the Reference and the Device Under Test.
Read the detailed description
The purpose of this study is to collect data to validate the respiratory rate performance of the Medical Health Tag developed by Spire Health. The Medical Health Tag respiratory rate will be evaluated during non-motion conditions over the range a range of 5-50 breaths per minute via Reference EtCO2. A FDA cleared, GE Healthcare S5 Multi-parameter monitoring system with End Tidal Carbon Dioxide (EtCO2) and 3-lead ECG will be used for the Respiratory and Pulse Rate References. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population.
This study will focus on the respiratory rate, RR parameter. The Spire Medical Health Tag is investigational and has not been cleared by the FDA. The intended purpose of the device under test is spot-checking, non-invasive monitoring / logging of respiratory rate on humans. For this evaluation, the device will be run in a continuous data collection mode.
The study population will include 20 healthy competent adults, ages 18 years and older. The subject selection will be a mix of males and females with small to large physiques. The subjects must understand the study and consent to participate by signing the Informed Consent Form. The subjects must be healthy showing no evidence of medical problems as indicated by satisfactorily completing the health assessment form and passing the health screening. Eligible subjects need to meet all of the inclusion criteria and none of the exclusion criteria for participation.
It is expected that the data collection will take approximately 4-7 days to complete. There is no additional followup required for the investigation.
The data from the Device Under Test will be collected on an application installed on the iOS or Android mobile device separate from the reference equipment.
Multi-parameter monitor used during the study to observe a subject's vital signs include ECG tracing, heart rate, respiratory rate, and EtCO2 with capnograph.
- GE Healthcare S5 Compact Monitor, M-NESTPR module with ECG, and/or Multi-parameter monitor
- Portable oxygen tank, mask and ambu bag
- GE Healthcare (Datex-Ohmeda) 3900 TruTrak+ / OxyTip+ Oxy-F-UN or Oxy-AF Sensor and Oxy-OL3 cable (SpO2 monitoring)
- Blood pressure cuff and stethoscope
Currently the FDA defines respiration rate devices as Class II devices. The Device Under Test in this study is considered non-significant risk device.
There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population.
- Conditions
- Respiratory Rate
- Being tested
- Spire Medical Health Tag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spire Medical Health TagDevice
Also called GE Healthcare S5 Multi-parameter monitoring system, End Tidal Carbon Dioxide (EtCO2), 3- lead ECG
Collect data to validate the respiratory rate performance of the Medical Health Tag developed by Spire Health. The Medical Health Tag respiratory rate will be evaluated during non-motion conditions over the range a range of 5-50 breaths per minute via Reference EtCO2.
A FDA cleared, GE Healthcare S5 Multi-parameter monitoring system with End Tidal Carbon Dioxide (EtCO2) and 3- lead ECG will be used for the Respiratory and Pulse Rate References.
| Study group | Role | What they receive |
|---|---|---|
| Spire Medical Health Tag | Experimental | Spire Medical Health Tag is worn by all subjects The study is open label Receives: Device: Spire Medical Health Tag |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of respiratory rate to the Reference
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 EtCO2 (Ref) for all stable respiratory periods
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start4 Jun 2019
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spire, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
- Investigators
- Dena Raley, BS, Study director, CTO Clinimark LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104737
- Sponsor's protocol ID
- PR 2019-330
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share individual data
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spire Medical Health Tag Respiratory Rate Validation in Adults
- ClinicalTrials.gov ID
- NCT04104737
- Acronym / sponsor ID
- PR 2019-330
- Conditions
- Respiratory Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Spire, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 26 Sep 2019 (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.
The primary purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the Spire Medical Health Tag to a FDA cleared End Tidal Carbon Dioxide monitor Reference Standard (GE Datex-Ohmeda).
After IRB approval, a minimum of 20 healthy volunteer test subjects, 18 or older will be entered into this study designed to validate the accuracy of the respiratory rate feature of the Spire Medical Health Tag (Device Under Test).
The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMIs. Each subject will be connected to a FDA cleared EtCO2 monitor (GE Datex-Ohmeda) and will be instrumented with a mouthpiece or open system mask that allows for measurement of EtCO2 derived respiratory rate. A range of stable respiratory rates will be elicited from each volunteer test subject with the use of a paced breathing application on a mobile phone. Subjects will also be connected to a 3-lead ECG (GE Datex-Ohmeda) for the purpose of monitoring heart rate and comparing to the pulse rate measurements recorded by the Spire Medical Health Tag.
The respiratory rate and pulse rate will be measured simultaneously for the Reference and the Device Under Test.
Detailed description
The purpose of this study is to collect data to validate the respiratory rate performance of the Medical Health Tag developed by Spire Health. The Medical Health Tag respiratory rate will be evaluated during non-motion conditions over the range a range of 5-50 breaths per minute via Reference EtCO2. A FDA cleared, GE Healthcare S5 Multi-parameter monitoring system with End Tidal Carbon Dioxide (EtCO2) and 3-lead ECG will be used for the Respiratory and Pulse Rate References. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population.
This study will focus on the respiratory rate, RR parameter. The Spire Medical Health Tag is investigational and has not been cleared by the FDA. The intended purpose of the device under test is spot-checking, non-invasive monitoring / logging of respiratory rate on humans. For this evaluation, the device will be run in a continuous data collection mode.
The study population will include 20 healthy competent adults, ages 18 years and older. The subject selection will be a mix of males and females with small to large physiques. The subjects must understand the study and consent to participate by signing the Informed Consent Form. The subjects must be healthy showing no evidence of medical problems as indicated by satisfactorily completing the health assessment form and passing the health screening. Eligible subjects need to meet all of the inclusion criteria and none of the exclusion criteria for participation.
It is expected that the data collection will take approximately 4-7 days to complete. There is no additional followup required for the investigation.
The data from the Device Under Test will be collected on an application installed on the iOS or Android mobile device separate from the reference equipment.
Multi-parameter monitor used during the study to observe a subject's vital signs include ECG tracing, heart rate, respiratory rate, and EtCO2 with capnograph.
- GE Healthcare S5 Compact Monitor, M-NESTPR module with ECG, and/or Multi-parameter monitor
- Portable oxygen tank, mask and ambu bag
- GE Healthcare (Datex-Ohmeda) 3900 TruTrak+ / OxyTip+ Oxy-F-UN or Oxy-AF Sensor and Oxy-OL3 cable (SpO2 monitoring)
- Blood pressure cuff and stethoscope
Currently the FDA defines respiration rate devices as Class II devices. The Device Under Test in this study is considered non-significant risk device.
There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spire Medical Health Tag | Experimental | Device: Spire Medical Health TagSpire Medical Health Tag is worn by all subjects The study is open label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
- 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. (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
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 |
|---|---|---|
| Spire Medical Health TagAlso: GE Healthcare S5 Multi-parameter monitoring system, End Tidal Carbon Dioxide (EtCO2), 3- lead ECGCollect data to validate the respiratory rate performance of the Medical Health Tag developed by Spire Health. The Medical Health Tag respiratory rate will be evaluated during non-motion conditions over the range a range of 5-50 breaths per minute via Reference EtCO2. A FDA cleared, GE Healthcare S5 Multi-parameter monitoring system with End Tidal Carbon Dioxide (EtCO2) and 3- lead ECG will be used for the Respiratory and Pulse Rate References. | Device | Spire Medical Health Tag |
Primary outcome
measurement of respiratory rate to the Reference
Time frame: 60 seconds
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 EtCO2 (Ref) for all stable respiratory periods
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 30 Oct 2019.
- Individual participant dataSharing planned: No. No plan to share individual data
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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.
Dena Raley, BS study director
CTO Clinimark LLC.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spire Medical Health Tag in people with Respiratory Rate, run by Spire, Inc. at 2 sites 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 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 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
measurement of respiratory rate to the Reference (time frame: 60 seconds). 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 30 Oct 2019.