HealthyNonin4NCT01762722
Nonin 4 Wavelength Cerebral Oximeter Study
A study testing Reduction of inspired oxygen in people with Healthy, run by Duke University 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 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Reduction of inspired oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2012
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21 to 35 years of age
- American Society of Anesthesiologists health assessment level 1
- Body Mass Index (BMI) 18 to 30
Who cannot join
- anemia
- hemoglobinopathy (e.g. sickle cell disease, thalassemia)
- positive pregnancy test (females)
- significant cardiac or pulmonary disease
- history of sleep apnea
- tobacco, drug or alcohol abuse
Show all 9Show fewer
- difficult airway
- abnormal EKG / pulmonary function test / room air saturation
- intolerance to breathing mask apparatus
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Calibration and Validation of the 4 Wavelength Nonin Non-invasive Cerebral Oxygen Saturation Oximeter and Cerebral Sensor
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 v 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%. Two 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 maintaining the arterial carbon dioxide level at 40 mmHg.
The study consists of 3 sequences:
- First sequence: reduction in arterial oxygen saturation in approximately 5% increments from 100 to 70% followed by return to room air and then a period of supplemental oxygen.
- Second sequence: reduction in arterial oxygen saturation in a single drop from 100 to 70% followed by return to room air and then a period of supplemental oxygen.
- Third sequence: reduction in arterial oxygen saturation in approximately 10% increments from 100 to 70% with alteration of carbon dioxide level from 35 to 45 mmHg at each interval followed by return to room air.
- Conditions
- Healthy
- Being tested
- Reduction of inspired oxygen
- Keywords
- Spectroscopy, near infrared, Oximetry, Hypoxemia, Tissue oxygenation
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of inspired oxygenDevice
Also called Nonin Equanox 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 |
|---|---|---|
| Desaturation | 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: Reduction of inspired oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Sensor
A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.
Measured: Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionApr 2012
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 HealthyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Nonin Medical, Inc
- Responsible party
- Principal investigator, David MacLeod, Duke University
- Investigators
- David B MacLeod, FRCA, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762722
- Sponsor's protocol ID
- Pro00018006
- Acronym
- Nonin4
- Status last verified
- Mar 2013
- First submitted
- 17 Feb 2012
- Last updated
- 16 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
MacLeod DB, Ikeda K, Vacchiano C, Lobbestael A, Wahr JA, Shaw AD. Development and validation of a cerebral oximeter capable of absolute accuracy. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1007-14. doi: 10.1053/j.jvca.2012.06.010. Epub 2012 Aug 9.
PubMed 22883447
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration and Validation of the 4 Wavelength Nonin Non-invasive Cerebral Oxygen Saturation Oximeter and Cerebral Sensor
- ClinicalTrials.gov ID
- NCT01762722
- Acronym / sponsor ID
- Nonin4 / Pro00018006
- Conditions
- Healthy
- Keywords
- Spectroscopy, near infrared, Oximetry, Hypoxemia, Tissue oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Nonin Medical, Inc
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Jan 2013 (estimated)
- Results
- Posted 16 Apr 2013
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 v 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%. Two 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 maintaining the arterial carbon dioxide level at 40 mmHg.
The study consists of 3 sequences:
- First sequence: reduction in arterial oxygen saturation in approximately 5% increments from 100 to 70% followed by return to room air and then a period of supplemental oxygen.
- Second sequence: reduction in arterial oxygen saturation in a single drop from 100 to 70% followed by return to room air and then a period of supplemental oxygen.
- Third sequence: reduction in arterial oxygen saturation in approximately 10% increments from 100 to 70% with alteration of carbon dioxide level from 35 to 45 mmHg at each interval followed by return to room air.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desaturation | Experimental | Device: Reduction of inspired oxygenHuman 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
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 21 to 35 years of age
- American Society of Anesthesiologists health assessment level 1
- Body Mass Index (BMI) 18 to 30
Key exclusion criteria (9 listed)
- anemia
- hemoglobinopathy (e.g. sickle cell disease, thalassemia)
- positive pregnancy test (females)
- significant cardiac or pulmonary disease
- history of sleep apnea
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 |
|---|---|---|
| Reduction of inspired oxygenAlso: Nonin Equanox 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 | Desaturation |
Primary outcome
Accuracy of Sensor
Time frame: Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.
A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22883447MacLeod DB, Ikeda K, Vacchiano C, Lobbestael A, Wahr JA, Shaw AD. Development and validation of a cerebral oximeter capable of absolute accuracy. J Cardiothorac Vasc Anesth. 2012 Dec;26(6):1007-14. doi: 10.1053/j.jvca.2012.06.010. Epub 2012 Aug 9.
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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 Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction of inspired oxygen in people with Healthy, run by Duke University 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 3 inclusion and 9 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 16 Apr 2013. 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?
Yes. Results are posted in the registry (first posted 16 Apr 2013). 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 Sensor (time frame: Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.). 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 NCT01762722, 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 16 Apr 2013.