HypoxiaNCT05359328
RDS MultiSense® SpO2 Validation Study
A study testing Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line in people with Hypoxia, run by Rhythm Diagnostic Systems at 1 site in United States.
Trial summary
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to arterial blood samples assessed by measuring carbon monoxide (CO) bound to hemoglobin by… 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 and Arterial line
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 29 Apr 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
- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
- Participant must have the ability to understand and provide written informed consent
- Participant is 18 to 50 years of age
- Participant must be willing and able to comply with study procedures and duration
- Participant is a non-smoker or who has not smoked within 2 days prior to the study
Who cannot join
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, wrist, hands, ears or forehead/skull or other sensor sites, tattoo, extensive moles, or freckles in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular sites utilized.)
- Female participants that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the participant is known to be not of child-bearing potential).
- Smoker participants who have refrained will be screened for Carboxyhemoglobin (COHb) levels >3% as assessed with a reference devie (Masimo Radical 7)
- Participants with known respiratory conditions (self-reported)
- Participants with known heart or cardiovascular conditions (self-reported, except for blood pressure and ECG review)
Show all 15Show fewer
- Self-reported health conditions as identified in the Health Assessment Form (self-reported)
- Participants with known clotting disorders (self-reported)
- Participants with severe contact allergies to standard adhesives, silicon, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
- Participants with severe allergies to iodine (only applicable if iodine is used)
- Participants with severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine)
- Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio < 0.4)
- Unwillingness or inability to remove colored nail polish from test digits.
- Unwillingness to have chest or other test sites 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
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to arterial blood samples assessed by measuring carbon monoxide (CO) bound to hemoglobin by CO-Oximetry. Additionally, data will be collected for heart rate accuracy as compared to reference ECG. The end goal is to provide supporting documentation for the SpO2 and heart rate accuracy validation for RDS MultiSense® Pulse Oximetry.
A minimum of 10 healthy adult male and female participants, ranging in age and pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by International Organization for Standardization ISO 80601-2-61:2017: corrected version 2018-02 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels.
The investigational device will be placed on the placed on the thorax of the participants (patch on the upper back and external electrode on the right pectoral) per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.
- Conditions
- Hypoxia
- Being tested
- Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line
- 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 Rate and Arterial lineDevice
Measurement of physiological parameters
| Study group | Role | What they receive |
|---|---|---|
| Controled Hypoxia - Healthy Volunteers | Other | Not described Receives: Device: Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of SpO2 accuracy performance of RDS MultiSense® Pulse Oximeter by comparison to CO-Oximeter
The Accuracy Root Mean Square (Arms) value will be used as a metric. Reference CO-Oximetry will be used as the basis for comparison for the investigational device SpO2 readings.
Measured: From beginning to end of controled hypoxia, up to 2 hours
Secondary outcomes (1)
Evaluation of heart rate accuracy performance of RDS MultiSense® by comparison to ECG-derived heart rate
The reference for comparison of the investigational device heart rate will be heart rate values collected from an ECG monitor.Heart rate accuracy will be assessed by review of the readings less than ±5 Beats Per Minute or ±10% from the Reference heart rate values.
Measured: From beginning to end of monitoring, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start26 Apr 2022
- Primary completion29 Apr 2022
- Study completion29 Apr 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhythm Diagnostic Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359328
- Sponsor's protocol ID
- PR 2022-466
- Status last verified
- Jul 2022
- First submitted
- 25 Apr 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 Validation Study
- ClinicalTrials.gov ID
- NCT05359328
- Acronym / sponsor ID
- PR 2022-466
- Conditions
- Hypoxia
- Keywords
- Hypoxia, Pulse Oximetry, SpO2, Remote Monitoring, Connected device, Real-time monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rhythm Diagnostic SystemsIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 3 May 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 clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to arterial blood samples assessed by measuring carbon monoxide (CO) bound to hemoglobin by CO-Oximetry. Additionally, data will be collected for heart rate accuracy as compared to reference ECG. The end goal is to provide supporting documentation for the SpO2 and heart rate accuracy validation for RDS MultiSense® Pulse Oximetry.
A minimum of 10 healthy adult male and female participants, ranging in age and pigmentation from light to dark, will be enrolled in the study to meet the study design requirements defined by International Organization for Standardization ISO 80601-2-61:2017: corrected version 2018-02 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels.
The investigational device will be placed on the placed on the thorax of the participants (patch on the upper back and external electrode on the right pectoral) per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.
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 Volunteers | Other | Device: Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance made up of either
- Participant must have the ability to understand and provide written informed consent
- Participant is 18 to 50 years of age
- Participant must be willing and able to comply with study procedures and duration
- Participant is a non-smoker or who has not smoked within 2 days prior to the study
Key exclusion criteria (15 listed)
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, wrist, hands, ears or forehead/skull or other sensor sites, tattoo, extensive moles, or freckles in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the particular sites utilized.)
- Female participants that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the participant is known to be not of child-bearing potential).
- Smoker participants who have refrained will be screened for Carboxyhemoglobin (COHb) levels >3% as assessed with a reference devie (Masimo Radical 7)
- Participants 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 Rate and Arterial lineMeasurement of physiological parameters | Device | Controled Hypoxia - Healthy Volunteers |
Primary outcome
Validation of SpO2 accuracy performance of RDS MultiSense® Pulse Oximeter by comparison to CO-Oximeter
Time frame: From beginning to end of controled hypoxia, up to 2 hours
The Accuracy Root Mean Square (Arms) value will be used as a metric. Reference CO-Oximetry will be used as the basis for comparison for the investigational device SpO2 readings.
1 secondary outcome
Evaluation of heart rate accuracy performance of RDS MultiSense® by comparison to ECG-derived heart rate
Time frame: From beginning to end of monitoring, up to 2 hours
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 and Arterial line 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 5 inclusion and 15 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?
Validation of SpO2 accuracy performance of RDS MultiSense® Pulse Oximeter by comparison to CO-Oximeter (time frame: From beginning to end of controled hypoxia, up to 2 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.