Oxygen DeficiencyNCT04584788
Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
A study testing Masimo O3 Regional Oximeter in people with Oxygen Deficiency, run by Masimo Corporation at 1 site in Netherlands.
Trial summary
Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Deficiency
- What is being tested?
- Masimo O3 Regional Oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Nov 2020to 2 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45 years, inclusive
- Willing and able to provide written informed consent
- Healthy subjects
Who cannot join
- Pregnant women
- Presence of any cardiovascular or pulmonary disease
- Exposure to high altitude(s) (>2000 m) within 30 days prior to the study
- Known allergy to intravenous contrast medium or heparin
- Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
- Patients deemed not suitable for the study at the discretion of the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.
- Conditions
- Oxygen Deficiency
- Being tested
- Masimo O3 Regional Oximeter
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo O3 Regional OximeterDevice
Study sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adult Volunteers | Experimental | Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived tissue oxygen saturation (rSO2) readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values. Receives: Device: Masimo O3 Regional Oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2
Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).
Measured: 1 visit up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start30 Nov 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxygen DeficiencyStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Medical Center Groningen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584788
- Sponsor's protocol ID
- SCHE0001
- Status last verified
- May 2022
- First submitted
- 6 Oct 2020
- Last updated
- 27 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
De Keijzer IN, Massari D, Niezen CK, Bokkers RPH, Vos JJ, Scheeren TWL. Agreement of somatic and renal near-infrared spectroscopy with reference blood samples during a controlled hypoxia sequence: a healthy volunteer study. J Clin Monit Comput. 2023 Jun;37(3):805-814. doi: 10.1007/s10877-022-00944-9. Epub 2022 Dec 4.
PubMed 36463540
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
- ClinicalTrials.gov ID
- NCT04584788
- Acronym / sponsor ID
- SCHE0001
- Conditions
- Oxygen Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University Medical Center Groningen
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 27 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adult Volunteers | Experimental | Device: Masimo O3 Regional OximeterControlled hypoxia will be induced and Masimo O3 regional oximeter-derived tissue oxygen saturation (rSO2) readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 45 years, inclusive
- Willing and able to provide written informed consent
- Healthy subjects
Key exclusion criteria (6 listed)
- Pregnant women
- Presence of any cardiovascular or pulmonary disease
- Exposure to high altitude(s) (>2000 m) within 30 days prior to the study
- Known allergy to intravenous contrast medium or heparin
- Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
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 |
|---|---|---|
| Masimo O3 Regional OximeterStudy sensors will be placed on somatic tissues. Readings will be taken from the tissues underneath the O3 sensors. | Device | Healthy Adult Volunteers |
Primary outcome
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2
Time frame: 1 visit up to 8 hours
Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36463540De Keijzer IN, Massari D, Niezen CK, Bokkers RPH, Vos JJ, Scheeren TWL. Agreement of somatic and renal near-infrared spectroscopy with reference blood samples during a controlled hypoxia sequence: a healthy volunteer study. J Clin Monit Comput. 2023 Jun;37(3):805-814. doi: 10.1007/s10877-022-00944-9. Epub 2022 Dec 4.
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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 Masimo O3 Regional Oximeter in people with Oxygen Deficiency, run by Masimo Corporation at 1 site in Netherlands.
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 3 inclusion and 6 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 27 Jun 2022. 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 27 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2 (time frame: 1 visit up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584788, which also lists 1 linked publication.
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 27 Jun 2022.