HypoxiaNCT06415786
OM2 Motion Verification Study
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 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2024to 27 Mar 2024
- 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: Healthy Male or Female volunteers age 18 to 50 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
- Male or female subjects 18 to 50 years of age
- 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
- Successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.
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)
- Females 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 COHb levels >3% as assessed by CO-Oximetry during the procedure
- tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
- MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
Show all 53Show fewer
- Subjects with known respiratory conditions such as:
- uncontrolled / severe asthma
- flu or influenza type infection
- 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 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
- 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 of 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.
About this study
Official title: Verification of Investigational Pulse Oximetry Devices During Motion and Non-Motion Conditions 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 reference-standard blood measurements during motion and non-motion conditions. 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 steady-state 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
- 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 during motion and non-motion conditions
Saturation accuracy in a diverse subject population over a specified saturation range during motion and non-motion conditions.
The acceptance criteria for the Nellcor™ Pro 7 Pulse Oximetry PCBA are as follows:
The acceptance criteria for SpO2 during motion and non-motion conditions across the saturation range of 70-100%:
Motion:
SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS)
Non-Motion:
SpO2 SC-A ±2 % (ARMS)
Measured: 2.5 hours
Verification of Pulse Rate during motion and non-motion conditions
The acceptance criteria for pulse rate during motion and non-motion conditions from 20-250 BPM over a specified saturation range of 70-100%:
Motion:
Pulse Rate Max-A ≤5% BPM (ARMS) Max-N ≤5% BPM (ARMS) OxySoft-N ≤5% BPM (ARMS)
Non-Motion:
Pulse Rate SC-A ≤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 posted16 May 2024
- Study start7 Mar 2024
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monica Rabanal, Principal investigator, Element Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415786
- Sponsor's protocol ID
- MDT23026OM2VMT
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Verification of Investigational Pulse Oximetry Devices During Motion and Non-Motion Conditions in Adult Volunteers
- ClinicalTrials.gov ID
- NCT06415786
- Acronym / sponsor ID
- MDT23026OM2VMT
- Conditions
- Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 16 May 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 reference-standard blood measurements during motion and non-motion conditions. 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 steady-state 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 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Male or Female volunteers age 18 to 50 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 (7 listed)
- Male or female subjects 18 to 50 years of age
- 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 (53 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)
- Females 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 COHb levels >3% as assessed by CO-Oximetry during the procedure
- tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
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 during motion and non-motion conditions
Time frame: 2.5 hours
Saturation accuracy in a diverse subject population over a specified saturation range during motion and non-motion conditions. The acceptance criteria for the Nellcor™ Pro 7 Pulse Oximetry PCBA are as follows: The acceptance criteria for SpO2 during motion and non-motion conditions across the saturation range of 70-100%: Motion: SpO2 Max-A ±3% (ARMS) Max-N ±3% (ARMS) OxySoft-N ±3% (ARMS) Non-Motion: SpO2 SC-A ±2 % (ARMS)
Verification of Pulse Rate during motion and non-motion conditions
Time frame: 2.5 hours
The acceptance criteria for pulse rate during motion and non-motion conditions from 20-250 BPM over a specified saturation range of 70-100%: Motion: Pulse Rate Max-A ≤5% BPM (ARMS) Max-N ≤5% BPM (ARMS) OxySoft-N ≤5% BPM (ARMS) Non-Motion: Pulse Rate SC-A ≤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.
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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.
Monica Rabanal principal investigator
Element Labs
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 7 inclusion and 53 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 during motion and non-motion conditions (time frame: 2.5 hours). The study lists 2 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.