SpO2 (Peripheral Oxygen Saturation) Measurement ValidationNCT05683366
Philps FAST2022 picoSAT Pulse Oximetry Desaturation Study
An observational study of SpO2 (Peripheral Oxygen Saturation) Measurement Validation, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- SpO2 (Peripheral Oxygen Saturation) Measurement Validation
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2022to 7 Sep 2023
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The population will include healthy non-smoking (or refrained from smoking for 2 days) competent adults, 18-50 yrs of age. It is planned that a sufficient number of participants will be screened to enroll in order to collect a minimum of 200 data points per sensor between 60 completed participants. Enrolled participants will be separated into 2 test groups of 30 completed participants. Each test group will consist of a minimum of 10 participants, with a min. of 3 males and 3 females, per each broad skin pigmentation category of light, medium, and dark.
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
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 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 COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow) Participants with known respiratory conditions such as: (self-reported) uncontrolled / severe asthma flu pneumonia / bronchitis shortness of breath / respiratory distress unresolved respiratory or lung surgery with continued indications of health issues, emphysema, COPD, lung disease Participants with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review) hypertension: systolic >140mmHg, Diastolic >90mmHg 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 (reviewed during health screen) 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 vascular diseases of the limbs Self-reported health conditions as identified in the Health Assessment Form (self-reported) 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 symptomatic head injury (within the last 2 months) cancer / chemotherapy Self-reported dermatological conditions at application site severe dermatitis, hyperkeratosis (e.g., ichthyosis), nail fungus Participants with known clotting disorders (self-reported) history of bleeding disorders or personal history of prolonged bleeding from injury history of blood clots hemophilia current use of blood thinner: prescription or daily use of aspirin Sickle Cell Trait or Disease Participants 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) 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. Dye injection within the past 48 hours Other known health condition, should be considered upon disclosure in health assessment form Dysfunctional hemoglobin levels
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Philps FAST picoSAT Pulse Oximetry Desaturation Study
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
Read the detailed description
To validate SpO2 accuracy performance of various SpO2 sensors with the Philips FAST Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry
- Being tested
- No Intervention
- Keywords
- Pulse Oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionDevice
There is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| Single Group | No interventions, single group. Receives: Device: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Over 70-100% SpO2, an ARMS of ≤ 3.5% in non-motion conditions for the following SpO2 Sensor: 4053
Measured: 13DEC2022-Q3 2023
Secondary outcomes (1)
Over 70-100% SpO2, an ARMS of ≤ 3% in non-motion conditions for the following SpO2 Sensors: 989803128591, 989803205881, 989803205891, 989803205911, 989803205831, 989803205381, MAXAI, MAXNI, OxySoftN, 4004, and 4052
Over 70-100% SpO2, an ARMS of ≤ 2% in non-motion conditions for the following SpO2 Sensors: 989803144381, 989803205851, 4000, 4050, and 2258
- Mean bias and limits of agreement for paired observations (SpO2 sensors and CO-Oximeter Over 70-100% SpO2, an ARMS within 1% among the broad categories of light, medium, and dark skin pigmentation for each SpO2 sensor under test Mean bias and limits of agreement for paired observations (SpO2 sensors and CO-Oximeter)
Measured: 20DEC2022 - Q3 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start13 Dec 2022
- Primary completion7 Sep 2023
- Study completion7 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpO2 (Peripheral Oxygen Saturation) Measurement ValidationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683366
- Sponsor's protocol ID
- MA_PM_FAST 2022_2022_11492
- Status last verified
- Apr 2024
- First submitted
- 4 Jan 2023
- Last updated
- 3 Apr 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Philps FAST picoSAT Pulse Oximetry Desaturation Study
- ClinicalTrials.gov ID
- NCT05683366
- Acronym / sponsor ID
- MA_PM_FAST 2022_2022_11492
- Keywords
- Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 7 Sep 2023 (actual)
- Study completion
- 7 Sep 2023 (actual)
- First posted
- 13 Jan 2023 (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.
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
Detailed description
To validate SpO2 accuracy performance of various SpO2 sensors with the Philips FAST Pulse Oximetry system during non-motion conditions over the range of 70-100% SaO2, arterial blood samples, assessed by CO-Oximetry
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | – | Device: No InterventionNo interventions, single group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population will include healthy non-smoking (or refrained from smoking for 2 days) competent adults, 18-50 yrs of age. It is planned that a sufficient number of participants will be screened to enroll in order to collect a minimum of 200 data points per sensor between 60 completed participants. Enrolled participants will be separated into 2 test groups of 30 completed participants. Each test group will consist of a minimum of 10 participants, with a min. of 3 males and 3 females, per each broad skin pigmentation category of light, medium, and dark.
Key inclusion criteria (4 listed)
- Subject must have the ability to understand and provide written informed consent
Key exclusion criteria (3 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 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 COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow) Participants with known respiratory conditions such as: (self-reported) uncontrolled / severe asthma flu pneumonia / bronchitis shortness of breath / respiratory distress unresolved respiratory or lung surgery with continued indications of health issues, emphysema, COPD, lung disease Participants with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review) hypertension: systolic >140mmHg, Diastolic >90mmHg 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 (reviewed during health screen) 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 vascular diseases of the limbs Self-reported health conditions as identified in the Health Assessment Form (self-reported) 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 symptomatic head injury (within the last 2 months) cancer / chemotherapy Self-reported dermatological conditions at application site severe dermatitis, hyperkeratosis (e.g., ichthyosis), nail fungus Participants with known clotting disorders (self-reported) history of bleeding disorders or personal history of prolonged bleeding from injury history of blood clots hemophilia current use of blood thinner: prescription or daily use of aspirin Sickle Cell Trait or Disease Participants 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) 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. Dye injection within the past 48 hours Other known health condition, should be considered upon disclosure in health assessment form Dysfunctional hemoglobin levels
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 |
|---|---|---|
| No InterventionThere is no intervention in this study | Device | Single Group |
Primary outcome
Over 70-100% SpO2, an ARMS of ≤ 3.5% in non-motion conditions for the following SpO2 Sensor: 4053
Time frame: 13DEC2022-Q3 2023
1 secondary outcome
Over 70-100% SpO2, an ARMS of ≤ 3% in non-motion conditions for the following SpO2 Sensors: 989803128591, 989803205881, 989803205891, 989803205911, 989803205831, 989803205381, MAXAI, MAXNI, OxySoftN, 4004, and 4052
Time frame: 20DEC2022 - Q3 2023
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 3 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for SpO2 (Peripheral Oxygen Saturation) Measurement Validation
Not yet recruiting
SpO2 Infant and Pediatric Study
SpO2 (Peripheral Oxygen Saturation) Measurement Validation, SpO2
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 SpO2 (Peripheral Oxygen Saturation) Measurement Validation, run by Philips Clinical & Medical Affairs Global 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 4 inclusion and 3 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 3 Apr 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?
Over 70-100% SpO2, an ARMS of ≤ 3.5% in non-motion conditions for the following SpO2 Sensor: 4053 (time frame: 13DEC2022-Q3 2023). 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 3 Apr 2024.