Next Gen Philips Optimus MRI pulse oximeter sensor validation

SPO2 NEXT GEN VALIDATION STUDY - PHILIPS OPTIMUS

This will test how accurately Philips MRI pulse oximeter sensors measure blood oxygen (SpO2) in adults aged 18–50 during non-moving conditions.

Quick facts

• Study type: Observational
• Enrollment: 36 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Philips Clinical & Medical Affairs Global (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Louisville, Colorado)
• Trial ID: NCT07521735 on ClinicalTrials.gov

What this trial studies

This observational project compares the Philips MR400 Pro MRI Patient Monitoring pulse oximeter sensors to arterial blood oxygen measured by CO-oximetry across the SaO2 range of 70–100% under non-motion conditions. Adult volunteers aged 18–50 who can provide written consent and meet inclusion/exclusion criteria will have simultaneous oximeter readings and arterial blood samples taken. The primary outcome is SpO2 accuracy calculated by comparing device readings to laboratory CO-oximetry results. Individuals with morbid obesity, compromised peripheral circulation, tattoos or wounds in sensor paths, or who are pregnant are excluded, and testing is performed at a single site.

Who should consider this trial

Good fit: Adults aged 18–50 who can give written informed consent, have intact sensor sites, have not smoked within 2 days, and meet other inclusion criteria are ideal candidates.

Not a fit: People outside the 18–50 age range, pregnant women, those with morbid obesity, compromised circulation, or tattoos/skin issues at sensor sites may not be eligible or benefit.

Why it matters

Potential benefit: If successful, the sensors could provide more reliable oxygen readings during MRI scans, improving patient monitoring and safety.

How similar studies have performed: Other pulse oximeter validation studies using CO-oximetry have commonly supported device accuracy, though MRI-specific sensor validations are less frequently reported.

Eligibility criteria

Inclusion Criteria:

* Participant must have the ability to understand and provide written informed consent.
* Participant is an adult between 18-50 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.
* Male or female assigned at birth of any race.

Exclusion Criteria:

* Participant is considered as being morbidly obese (defined as BMI \>39.5)
* Compromised circulation (i.e., Raynaud's Syndrome), injury, open wound, 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. Tattoos 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 sites utilized.)
* Females who are pregnant
* Females who are trying to get pregnant (with confirmation of positive urine pregnancy test unless the participant is known to be not of child-bearing potential)
* Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with 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,
  * emphysema, COPD, lung disease
  * Recent COVID with or without hospitalization (last 2 months)
* Participants with self-reported heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)

  * high blood pressure: systolic \>140 mmHg or diastolic \>90 mmHg on 3 consecutive readings (reviewed during health screen)
  * have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA)
  * 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
  * implantable active medical device such as pacemaker or automatic defibrillator
* 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 symptomatic head injury (within the last 2 months),
  * Cancer requiring chemotherapy, radiation, or current treatment.
* 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 self-reported dermatological conditions at sensor application sites

  * severe dermatitis
  * hyperkeratosis
  * nail fungus
* Participants with severe contact allergies to standard adhesives, latex, silicone 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)
* Participants with allergies to ultrasound gel
* Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio \<0.4)
* Unwillingness or inability to remove nail polish, nail jewelry, or artificial nails from test digits. Bruised nail bed of test digits (Note: Certain bruising may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
* Unwillingness or inability to cut/trim fingernail(s) of test digits if determined length will interfere with correct application of the sensor.
* Participant received intravascular dye within the past 48 hours (e.g. Indocyanine green, methylene blue, indiocarmine, dyes used in cardiac output monitoring)
* Surgical hardware in pathway of Device Under Test
* Other known health conditions should be considered upon disclosure in health assessment form.
* Participants with uneven skin tone at the sensor site or at the forehead
* Participants who were previously enrolled and/or included in the terminated Optimus Validation study

Where this trial is running

Louisville, Colorado

• Element Materials Technology — Louisville, Colorado, United States (RECRUITING)

Study contacts

• Study coordinator: Dominque Watson

Conditions: Pulse Oximetry