HypoxiaNCT06661889
OM2 Low Saturation Verification
An observational study of Hypoxia, run by Medtronic - MITG at 1 site in United States.
Trial summary
The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2024to 27 May 2025
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Male or Female volunteers age 18 to 39 years, weighing greater than 40kgs. Volunteers must be non-smokers or not smoked within 2 days prior to the study. Cleared a same day health assessment form and health screen to ensure none of the exclusion criteria was met. With a successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.
Who may be able to join
- Healthy volunteers 18 to ≤39 years
- Subject is willing and able to comply with study procedures and duration
- Subject is willing to sign an informed consent
- Subject weighs >40kg
- Subject is a non-smoker or has not smoked within 2 days prior to the study
- Cleared same day health assessment form and health screening
Who cannot join
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, 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 subjects to participate if the condition is noted and would not affect the sites utilized)
- Subjects of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study
- Subjects with known concurrent, active respiratory conditions such as:
- uncontrolled / severe asthma
- flu or influenza type infection
Show all 50Show fewer
- pneumonia / bronchitis
- shortness of breath / respiratory distress
- unresolved respiratory or lung surgery
- emphysema, COPD, lung disease
- recent COVID (last 2 months)
- Subjects with known heart or cardiovascular conditions such as:
- hypertension: systolic >140mmHg, or Diastolic >90mmHg on 3 consecutive readings
- have had cardiovascular surgery
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm and/or with respiratory sinus arrhythmia, at the discretion of the Principal Investigator or designee
- 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
- subjects with known clotting disorders
- history of bleeding disorders or personal history of prolonged bleeding from injury
- history of blood clots
- hemophilia
- sickle cell trait or disease
- current use of blood thinner: prescription or daily use such as aspirin
- 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
- participants with severe allergy to iodine (only applicable if iodine is used)
- subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
- arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
- history of clinically significant complications from previous arterial cannulation
- unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
- other known health condition, upon disclosure in Health Assessment form
Trial locations and contacts
1 site in 1 country.
United States1 site
Medtronic Clinical Physiology Lab
Denver, Colorado, 80218
About this study
Official title: Low Saturation Verification of Investigational Pulse Oximetry Devices in Adult Volunteers
The verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.
Read the detailed description
To verify the SpO2 and pulse rate accuracy in comparison to a reference standard blood measurements. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steadystate saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects.
- Conditions
- Hypoxia
- Keywords
- Low Saturation, Pulse Oximetry
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of Saturation Accuracy
Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range.
The acceptance criteria for SpO2 during low saturation conditions across the saturation range of 60-80%:
SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS) Max-Fast ±3%(ARMS)
Measured: 2.5 hours
Acceptance criteria for SpO2 accuracy across the saturation range of 70-100%:
Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for SpO2 during saturation conditions across the saturation range of 70-100%: SpO2 Max-A ±2% (ARMS) Max-N ±2% (ARMS) OxySoft-N ±2% (ARMS) Max-Fast ±2%(ARMS)
Measured: 2.5 hours
Acceptance criteria for pulse rate accuracy within 20-250 BPM
Pulse rate accuracy Max-A <=3 BPM (ARMS) Max-N <=3 BPM (ARMS) OxySoft-N <=3 BPM (ARMS) Max-Fast <=3 BPM(ARMS)
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start18 Nov 2024
- Primary completion27 Feb 2025
- Study completion27 May 2025
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randall M Clark, Principal investigator, Medtronic Clinical Physiology LaboratoryDavid Macleod, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661889
- Sponsor's protocol ID
- MDT23028OM2VLS
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Saturation Verification of Investigational Pulse Oximetry Devices in Adult Volunteers
- ClinicalTrials.gov ID
- NCT06661889
- Acronym / sponsor ID
- MDT23028OM2VLS
- Conditions
- Hypoxia
- Keywords
- Low Saturation, Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 28 Oct 2024 (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 verification of an investigational pulse oximetry board to verify pulse rate and saturation accuracy over a specified saturation range in diverse populations.
Detailed description
To verify the SpO2 and pulse rate accuracy in comparison to a reference standard blood measurements. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steadystate saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Observational study |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Male or Female volunteers age 18 to 39 years, weighing greater than 40kgs. Volunteers must be non-smokers or not smoked within 2 days prior to the study. Cleared a same day health assessment form and health screen to ensure none of the exclusion criteria was met. With a successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.
Key inclusion criteria (6 listed)
- Healthy volunteers 18 to ≤39 years
- Subject is willing and able to comply with study procedures and duration
- Subject is willing to sign an informed consent
- Subject weighs >40kg
- Subject is a non-smoker or has not smoked within 2 days prior to the study
Key exclusion criteria (50 listed)
- Subject is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation, injury, or physical malformation of fingers, 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 subjects to participate if the condition is noted and would not affect the sites utilized)
- Subjects of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study
- Subjects with known concurrent, active respiratory conditions such as:
- Subjects with known 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.
Primary outcome
Verification of Saturation Accuracy
Time frame: 2.5 hours
Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for SpO2 during low saturation conditions across the saturation range of 60-80%: SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS) Max-Fast ±3%(ARMS)
Acceptance criteria for SpO2 accuracy across the saturation range of 70-100%:
Time frame: 2.5 hours
Verification of Saturation Accuracy Saturation accuracy in a diverse subject population over a specified saturation range. The acceptance criteria for SpO2 during saturation conditions across the saturation range of 70-100%: SpO2 Max-A ±2% (ARMS) Max-N ±2% (ARMS) OxySoft-N ±2% (ARMS) Max-Fast ±2%(ARMS)
Acceptance criteria for pulse rate accuracy within 20-250 BPM
Time frame: 2.5 hours
Pulse rate accuracy Max-A <=3 BPM (ARMS) Max-N <=3 BPM (ARMS) OxySoft-N <=3 BPM (ARMS) Max-Fast <=3 BPM(ARMS)
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 14 May 2026.
- 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.
Randall M Clark principal investigator
Medtronic Clinical Physiology Laboratory
David Macleod principal investigator
Duke University
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 Hypoxia, run by Medtronic - MITG 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 50 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 14 May 2026. 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?
Verification of Saturation Accuracy (time frame: 2.5 hours). The study lists 3 primary outcomes in all. 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 14 May 2026.