A Minimum of 30 Adults, Ages 18 Years and OlderNCT05210712
Respiratory Rate Validation Study - RS001.2 Respiree Cardio-Respiratory Monitor
An observational study of A Minimum of 30 Adults, Ages 18 Years and Older, run by Respiree Pte Ltd at 1 site in United States.
Trial summary
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the RS001.2 Respiree Cardio-Respiratory Monitor to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- A Minimum of 30 Adults, Ages 18 Years and Older
- What is being tested?
- RS001.2 Respiree Cardio-Respiratory Monitor
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2022to 10 Feb 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The study population will include a minimum of 30 healthy competent adults, ages 18 years and older. A maximum of 60 subjects will be enrolled. The subject selection will be a mix of males and females with small to large physiques. An attempt will be made to enroll a variety of skin tones. The goal is to include a range of skin pigmentations, including at least 5 darkly pigmented subjects or 15% of the subject pool, whichever is larger. The subjects must understand the study and consent to participate by signing the Informed Consent Form. Subject enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of the exclusion criteria, a satisfactory health screen, and the subject and data demographics needed for the study.
Who may be able to join
- Subject must have the ability to understand and provide written informed consent
- Subject must be ≥18 years of age
- Subject must be willing and able to comply with study procedures and duration
- Male or female of any race
- Baseline SpO2 ≥85%
- At least 3 subjects (10% of a total 30 subjects) will have a history of smoking
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Subjects who refuse or are unable to provide to sign an informed written consent for study
- Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study
- 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,
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- flu,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- respiratory or lung surgery,
- Severe COPD
- Subjects with self-reported heart or cardiovascular conditions such as:
- high blood pressure: systolic >160 mmHg or diastolic >100 mmHg on 3 consecutive readings (reviewed during health screen)
- have had cardiovascular surgery
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (occasional PVCs is acceptable, less than two a minute)
- 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
- 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
- Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported)
- 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
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the RS001.2 Respiree Cardio-Respiratory Monitor to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda).
Read the detailed description
After IRB approval, a minimum of 30 volunteer test subjects will be enrolled for the final validation study population. A maximum of 60 subjects will be enrolled. All subjects will be 18 or older and selected to represent a range of body types including small, average, muscular, and large with a range of BMI's.
Each subject will be connected to a commonly used End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and the RS001.2 Respiree Cardio-Respiratory Monitor. The end tidal carbon dioxide (EtCO2) monitor will determine performance of respiratory rate metrics (Reference). Each subject will be instrumented with a mouthpiece or nasal cannula that allows for measurement of the EtCO2. Subjects will also be connected to a 3-lead ECG and pulse oximeter in order to monitor the subject's vital signs for safety purposes.
Subjects will be seated for the study. A range of stable respiratory rates will be elicited from each volunteer test subject. After a baseline data set at the subject natural respiratory rate, the rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40, 45, and 50 breaths per minute; with some natural variation from these exact numbers and tailored to the subject's capabilities. A paced breathing app will be used. It is expected that some of the subjects may not be able to be evaluated over the entire range as some subjects may not be able to breathe at the lower and higher respiratory rates. In this case, additional data may be recorded at the baseline range and other ranges that are comfortable for the subject. Once stable breathing at specified rate is achieved data will be collected for one to three minutes per respiratory rate plateau. Between plateaus, the subjects using a mouthpiece are allowed to take the mouthpiece out and relax.
The respiratory rate will be measured simultaneously with the Reference and the Device Under Test. During the stable plateaus at each level, the data will be averaged in approximately 60 second intervals. For final validation, the Reference EtCO2 waveform will be scored by counting the respiratory peaks per minute. The Accuracy root-mean-square (Arms) will be the basis for evaluation and acceptance.
To 'Pass' this test the RS001.2 Respiree Cardio-Respiratory Monitor (Device Under Test) must demonstrate an Accuracy root-mean-square (Arms) of ≤3 breaths per minute when compared to the Reference EtCO2 monitor.
- Being tested
- RS001.2 Respiree Cardio-Respiratory Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS001.2 Respiree Cardio-Respiratory MonitorDevice
The RS001.2 Respiree Cardio-Respiratory Monitor is intended as a noninvasive multiparameter monitor on the adult population
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the device to Reference
The primary objective of this study is to compare the accuracy of the device under test for the measurement of respiratory rate to the Reference, which is an End Tidal Carbon Dioxide Monitor (EtCO2). For final validation, the EtCO2 waveform will be scored by counting the respiratory peaks per minute.
Measured: 1 to 3 minutes at a given level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start24 Jan 2022
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A Minimum of 30 Adults, Ages 18 Years and OlderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respiree Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210712
- Sponsor's protocol ID
- 2021-462
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Rate Validation Study - RS001.2 Respiree Cardio-Respiratory Monitor
- ClinicalTrials.gov ID
- NCT05210712
- Acronym / sponsor ID
- 2021-462
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Respiree Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 27 Jan 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.
The purpose of this study is to conduct a Respiratory Rate accuracy validation comparing the RS001.2 Respiree Cardio-Respiratory Monitor to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda).
Detailed description
After IRB approval, a minimum of 30 volunteer test subjects will be enrolled for the final validation study population. A maximum of 60 subjects will be enrolled. All subjects will be 18 or older and selected to represent a range of body types including small, average, muscular, and large with a range of BMI's.
Each subject will be connected to a commonly used End Tidal Carbon Dioxide monitor (GE Datex-Ohmeda) and the RS001.2 Respiree Cardio-Respiratory Monitor. The end tidal carbon dioxide (EtCO2) monitor will determine performance of respiratory rate metrics (Reference). Each subject will be instrumented with a mouthpiece or nasal cannula that allows for measurement of the EtCO2. Subjects will also be connected to a 3-lead ECG and pulse oximeter in order to monitor the subject's vital signs for safety purposes.
Subjects will be seated for the study. A range of stable respiratory rates will be elicited from each volunteer test subject. After a baseline data set at the subject natural respiratory rate, the rates will be approximately 5, 10, 15, 20, 25, 30, 35, 40, 45, and 50 breaths per minute; with some natural variation from these exact numbers and tailored to the subject's capabilities. A paced breathing app will be used. It is expected that some of the subjects may not be able to be evaluated over the entire range as some subjects may not be able to breathe at the lower and higher respiratory rates. In this case, additional data may be recorded at the baseline range and other ranges that are comfortable for the subject. Once stable breathing at specified rate is achieved data will be collected for one to three minutes per respiratory rate plateau. Between plateaus, the subjects using a mouthpiece are allowed to take the mouthpiece out and relax.
The respiratory rate will be measured simultaneously with the Reference and the Device Under Test. During the stable plateaus at each level, the data will be averaged in approximately 60 second intervals. For final validation, the Reference EtCO2 waveform will be scored by counting the respiratory peaks per minute. The Accuracy root-mean-square (Arms) will be the basis for evaluation and acceptance.
To 'Pass' this test the RS001.2 Respiree Cardio-Respiratory Monitor (Device Under Test) must demonstrate an Accuracy root-mean-square (Arms) of ≤3 breaths per minute when compared to the Reference EtCO2 monitor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will include a minimum of 30 healthy competent adults, ages 18 years and older. A maximum of 60 subjects will be enrolled. The subject selection will be a mix of males and females with small to large physiques. An attempt will be made to enroll a variety of skin tones. The goal is to include a range of skin pigmentations, including at least 5 darkly pigmented subjects or 15% of the subject pool, whichever is larger. The subjects must understand the study and consent to participate by signing the Informed Consent Form. Subject enrollment and participation in this clinical study is based on meeting the inclusion criteria and none of the exclusion criteria, a satisfactory health screen, and the subject and data demographics needed for the study.
Key inclusion criteria (6 listed)
- Subject must have the ability to understand and provide written informed consent
- Subject must be ≥18 years of age
- Subject must be willing and able to comply with study procedures and duration
- Male or female of any race
- Baseline SpO2 ≥85%
Key exclusion criteria (37 listed)
- Subjects who refuse or are unable to provide to sign an informed written consent for study
- Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study
- 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:
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 |
|---|---|---|
| RS001.2 Respiree Cardio-Respiratory MonitorThe RS001.2 Respiree Cardio-Respiratory Monitor is intended as a noninvasive multiparameter monitor on the adult population | Device | – |
Primary outcome
Accuracy of the device to Reference
Time frame: 1 to 3 minutes at a given level
The primary objective of this study is to compare the accuracy of the device under test for the measurement of respiratory rate to the Reference, which is an End Tidal Carbon Dioxide Monitor (EtCO2). For final validation, the EtCO2 waveform will be scored by counting the respiratory peaks per minute.
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 2 May 2022.
- Individual participant dataSharing planned: No
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?
An observational study of A Minimum of 30 Adults, Ages 18 Years and Older, run by Respiree Pte 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 37 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 2 May 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?
Accuracy of the device to Reference (time frame: 1 to 3 minutes at a given level). 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 2 May 2022.