HealthyPhase 2NCT01418079
Accuracy of the O2 MedTech PMS-3000 Monitor
A Phase 2 study testing O2 MedTech cerebral oximeter (Oxygen desaturation) in people with Healthy, run by O2 MedTech, Inc. at 1 site in United States.
Trial summary
A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- O2 MedTech cerebral oximeter (Oxygen desaturation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Feb 2012
- Phase
- Phase 2
- 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
Who may be able to join
- Body Mass Index (BMI) of 18 to 30, inclusive
- No anticoagulant or platelet inhibitor use
- Oxygen saturation (SpO2) ≥ 95% on room air
- Able to tolerate breathing mask apparatus
Who cannot join
- Female with positive pregnancy test
- Beard or history of or anatomy suggestive of difficult airway
- Lab values outside normal range for the clinical site
- History of cigarette smoking or currently a cigarette smoker
- Current drug or alcohol abuse
- History of sleep apnea, high blood pressure (HBP), cardiac or pulmonary disease, gastroesophageal reflux, hemoglobinopathy, or coagulation abnormality
- Known allergy to lidocaine or heparin
- Abnormal electrocardiogram (ECG)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Accuracy of the O2 MedTech PMS-3000 Monitor for the Non-invasive Measurement of Cerebral and Tissue Oxygenation Using Phase-modulated Infrared Spectroscopy
A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the forehead that both emits and detects the amount of light absorbed. This study will determine how accurate the device is by comparing the displayed value on the monitor with blood samples taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In order to test the device over a suitable range, the level of oxygen within the blood will be reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy volunteers.
Read the detailed description
This is a calibration and validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation non-invasively. This is achieved by comparing NIRS-derived cerebral tissue oxygen saturation with a calculated value derived from simultaneous arterial and jugular venous blood samples.
At present the FDA have adopted the standards published in 2005 by the International Organization for Standardization (ISO), entitled ISO 9919. This is a set of technical specifications and guidelines for pulse oximeters, which share certain technical similarities to cerebral oximeters. In particular, Annex EE details the conduct of a controlled desaturation study for the calibration of pulse oximeter equipment. Specifically, the fraction of inspired oxygen delivered to test subjects is varied to achieve a series of targeted steady state saturation periods over a range of arterial oxygen saturation of 70 - 100%.
While cerebral oximeters differ from pulse oximeters in terms of the what is being measured (brain tissue versus arterial blood) the FDA have maintained the requirement to examine data from human volunteer studies in which the arterial oxygen saturation ranges from 70 - 100%. Several FDA-approved cerebral oximeters were validated in a similar manner.
The device controlling the inspired gas concentration is the RespirAct, which permits precise reduction in the arterial oxygen saturation while also maintaining the arterial carbon dioxide level at a precise level.
The study consists of 2 sequences:
- First sequence: reduction in arterial oxygen saturation in approximately 5% increments from 100 to 70%, while maintaining the arterial carbon dioxide level at 40 mmHg, followed by return to room air and then a period of supplemental oxygen.
- Second sequence: reduction in arterial oxygen saturation in approximately 5% increments from 100 to 70%, while maintaining the arterial carbon dioxide level at a different level, followed by return to room air and then a period of supplemental oxygen.
- Conditions
- Healthy
- Being tested
- O2 MedTech cerebral oximeter (Oxygen desaturation)
- Keywords
- Spectroscopy, near infrared, cerebral oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2 MedTech cerebral oximeter (Oxygen desaturation)Device
Also called PMS-3000 cerebral oximeter
Reduction in blood oxygen saturation by sequential reduction in inspired gas composition. Steps are of 6 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
| Study group | Role | What they receive |
|---|---|---|
| PMS-3000 | Experimental | Human volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%. Receives: Device: O2 MedTech cerebral oximeter (Oxygen desaturation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of device to measure cerebral tissue oxygen saturation
Oximeter measurements are compared to co-oximeter measurements following each subject study. The total sample of subjects is needed to complete the analysis.
Measured: approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- O2 MedTech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- David B MacLeod, FRCA, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418079
- Sponsor's protocol ID
- MT2010001
- Status last verified
- May 2012
- First submitted
- 12 Aug 2011
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the O2 MedTech PMS-3000 Monitor for the Non-invasive Measurement of Cerebral and Tissue Oxygenation Using Phase-modulated Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT01418079
- Acronym / sponsor ID
- MT2010001
- Conditions
- Healthy
- Keywords
- Spectroscopy, near infrared, cerebral oxygenation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- O2 MedTech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- Aug 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Aug 2011 (estimated)
- 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.
A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the forehead that both emits and detects the amount of light absorbed. This study will determine how accurate the device is by comparing the displayed value on the monitor with blood samples taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In order to test the device over a suitable range, the level of oxygen within the blood will be reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy volunteers.
Detailed description
This is a calibration and validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation non-invasively. This is achieved by comparing NIRS-derived cerebral tissue oxygen saturation with a calculated value derived from simultaneous arterial and jugular venous blood samples.
At present the FDA have adopted the standards published in 2005 by the International Organization for Standardization (ISO), entitled ISO 9919. This is a set of technical specifications and guidelines for pulse oximeters, which share certain technical similarities to cerebral oximeters. In particular, Annex EE details the conduct of a controlled desaturation study for the calibration of pulse oximeter equipment. Specifically, the fraction of inspired oxygen delivered to test subjects is varied to achieve a series of targeted steady state saturation periods over a range of arterial oxygen saturation of 70 - 100%.
While cerebral oximeters differ from pulse oximeters in terms of the what is being measured (brain tissue versus arterial blood) the FDA have maintained the requirement to examine data from human volunteer studies in which the arterial oxygen saturation ranges from 70 - 100%. Several FDA-approved cerebral oximeters were validated in a similar manner.
The device controlling the inspired gas concentration is the RespirAct, which permits precise reduction in the arterial oxygen saturation while also maintaining the arterial carbon dioxide level at a precise level.
The study consists of 2 sequences:
- First sequence: reduction in arterial oxygen saturation in approximately 5% increments from 100 to 70%, while maintaining the arterial carbon dioxide level at 40 mmHg, followed by return to room air and then a period of supplemental oxygen.
- Second sequence: reduction in arterial oxygen saturation in approximately 5% increments from 100 to 70%, while maintaining the arterial carbon dioxide level at a different level, followed by return to room air and then a period of supplemental oxygen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PMS-3000 | Experimental | Device: O2 MedTech cerebral oximeter (Oxygen desaturation)Human volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) of 18 to 30, inclusive
- No anticoagulant or platelet inhibitor use
- Oxygen saturation (SpO2) ≥ 95% on room air
- Able to tolerate breathing mask apparatus
Key exclusion criteria (8 listed)
- Female with positive pregnancy test
- Beard or history of or anatomy suggestive of difficult airway
- Lab values outside normal range for the clinical site
- History of cigarette smoking or currently a cigarette smoker
- Current drug or alcohol abuse
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 |
|---|---|---|
| O2 MedTech cerebral oximeter (Oxygen desaturation)Also: PMS-3000 cerebral oximeterReduction in blood oxygen saturation by sequential reduction in inspired gas composition. Steps are of 6 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%. | Device | PMS-3000 |
Primary outcome
Accuracy of device to measure cerebral tissue oxygen saturation
Time frame: approximately 4 months
Oximeter measurements are compared to co-oximeter measurements following each subject study. The total sample of subjects is needed to complete the analysis.
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 23 May 2012.
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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.
David B MacLeod, FRCA 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?
A Phase 2 study testing O2 MedTech cerebral oximeter (Oxygen desaturation) in people with Healthy, run by O2 MedTech, Inc. 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 8 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 23 May 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Accuracy of device to measure cerebral tissue oxygen saturation (time frame: approximately 4 months). 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 23 May 2012.