HypoxiaNCT05466942
RDS MultiSense® SpO2 Calibration
A study testing Pulse Oximeter, Respiratory Rate, Heart Rate in people with Hypoxia, run by Rhythm Diagnostic Systems at 1 site in United States.
Trial summary
Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for comparison. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Pulse Oximeter, Respiratory Rate, Heart Rate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 20 Oct 2022
- 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 50 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 18 to 50 years of age
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who has not smoked within 2 days prior to the study.
- Male or female of any race
- Subject demographics include a range of skin pigmentations, including at least 3 darkly pigmented subjects or 15% of the subject pool, whichever is larger.
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, 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.)
- Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential)
- Subjects who have smoked in the last 2 days with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- Subjects with known respiratory conditions (self-reported)
- Subjects with known heart or cardiovascular conditions (self-reported, except for blood pressure and ECG review) or with an implantable active medical device such as pacemaker or automatic defibrillator
Show all 11Show fewer
- Self-reported health conditions as identified in the Health Assessment Form (self-reported)
- Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
- Unwillingness or inability to remove colored nail polish from test digits.
- Unwillingness to have chest or other test site shaved
- 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
Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for comparison. A minimum of fifteen (15) up to fifty (50) healthy adult subjects, ranging in pigmentation from light to dark, with at least six (6) subjects with dark pigmentation (Fitzpatrick 5-6), will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). SpO2 data will be evaluated during non-motion conditions. SpO2 data will be evaluated during stable step plateaus of induced hypoxic levels. The investigational device will be placed on the thorax of the subjects (patch on the upper back and external electrode on the right pectoral). Simultaneous data collection will be set up for the reference and the systems under test.
- Conditions
- Hypoxia
- Being tested
- Pulse Oximeter, Respiratory Rate, Heart Rate
- Keywords
- Hypoxia, Pulse Oximetry, SpO2, Remote monitoring, Connected device, Real-time monitoring
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse Oximeter, Respiratory Rate, Heart RateDevice
Measurement of physiological parameters
| Study group | Role | What they receive |
|---|---|---|
| Controled Hypoxia - Healthy volunteer | Other | Male and female subjects, ranging in pigmentation from light to dark Receives: Device: Pulse Oximeter, Respiratory Rate, Heart Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy.
Accuracy is defined as an average measurement variation less than 3.5% of the mean value to the reference standard. Reference Pulse Oximetry Systems, previously compared to Reference CO-Oximetry will be used as the basis for comparison. The study population will include 15 to 50 subjects. The data for analysis will be equally distributed across the range of 70-100%. All data will be used for the analysis unless identified as unstable by the control oximeter. Data that is found to be unstable will be removed prior to the comparative analysis.
Measured: from device placement to device removal, assessed up to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start15 Mar 2022
- Primary completion17 Mar 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhythm Diagnostic Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466942
- Sponsor's protocol ID
- PR 2022-465
- Status last verified
- Dec 2024
- First submitted
- 8 Jul 2022
- Last updated
- 19 Dec 2024
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RDS MultiSense® SpO2 Calibration
- ClinicalTrials.gov ID
- NCT05466942
- Acronym / sponsor ID
- PR 2022-465
- Conditions
- Hypoxia
- Keywords
- Hypoxia, Pulse Oximetry, SpO2, Remote monitoring, Connected device, Real-time monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rhythm Diagnostic SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Clinimark, LLC
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 17 Mar 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 20 Jul 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.
Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for comparison. A minimum of fifteen (15) up to fifty (50) healthy adult subjects, ranging in pigmentation from light to dark, with at least six (6) subjects with dark pigmentation (Fitzpatrick 5-6), will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). SpO2 data will be evaluated during non-motion conditions. SpO2 data will be evaluated during stable step plateaus of induced hypoxic levels. The investigational device will be placed on the thorax of the subjects (patch on the upper back and external electrode on the right pectoral). Simultaneous data collection will be set up for the reference and the systems under test.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controled Hypoxia - Healthy volunteer | Other | Device: Pulse Oximeter, Respiratory Rate, Heart RateMale and female subjects, ranging in pigmentation from light to dark |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject must have the ability to understand and provide written informed consent
- Subject is 18 to 50 years of age
- Subject must be willing and able to comply with study procedures and duration
- Subject is a non-smoker or who has not smoked within 2 days prior to the study.
- Male or female of any race
Key exclusion criteria (11 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, 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.)
- Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential)
- Subjects who have smoked in the last 2 days with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- Subjects with known respiratory conditions (self-reported)
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 |
|---|---|---|
| Pulse Oximeter, Respiratory Rate, Heart RateMeasurement of physiological parameters | Device | Controled Hypoxia - Healthy volunteer |
Primary outcome
Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy.
Time frame: from device placement to device removal, assessed up to 3 hours
Accuracy is defined as an average measurement variation less than 3.5% of the mean value to the reference standard. Reference Pulse Oximetry Systems, previously compared to Reference CO-Oximetry will be used as the basis for comparison. The study population will include 15 to 50 subjects. The data for analysis will be equally distributed across the range of 70-100%. All data will be used for the analysis unless identified as unstable by the control oximeter. Data that is found to be unstable will be removed prior to the comparative analysis.
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 19 Dec 2024.
- 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 Pulse Oximeter, Respiratory Rate, Heart Rate in people with Hypoxia, run by Rhythm Diagnostic Systems 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 11 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 19 Dec 2024. 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?
Determination of the quality of measurements of arterial blood saturation (SpO2) provided by the MultiSense® system in comparison to measurements made with a reference Pulse Oximetry System, in terms of accuracy. (time frame: from device placement to device removal, assessed up to 3 hours). 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 19 Dec 2024.