HealthyNCT05460585
Cerebral Oxygenation Values in Healthy Adults Volunteers Measured With RheoPatch and NIRO-200NX
An observational study of Healthy and Adults, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Noninvasive measurement of cerebral tissue oxygen saturation levels by near infrared spectroscopy (NIRS) is clinical routine in perioperative medicine. One of the main technical challenges of NIRS measurements is to eliminate the influence of signals of the skin and skull. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Cerebral oximetry using Rheopatch and Cerebral oximetry using NIRO-200NX
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2022to 10 May 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The project population consists of volunteers in subjective good health. Volunteers are chosen to minimize the effect of diseases on the measurements, as the investigators are interested in baseline measurement values and repeatability.
Who may be able to join
- Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- Informed Consent signed by the subject
- Subjective good health
Who cannot join
- The presence of any one of the following exclusion criteria will lead to the exclusion of the subject
- Age (<18, > 65 yrs.)
- Forehead skin disease
- Allergy to skin contacting components of NIRS-sensors
- Known cerebrovascular and heart diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cerebral Oxygenation Values in Healthy Adults
Noninvasive measurement of cerebral tissue oxygen saturation levels by near infrared spectroscopy (NIRS) is clinical routine in perioperative medicine. One of the main technical challenges of NIRS measurements is to eliminate the influence of signals of the skin and skull. A new device (RheoPatch, Luciole Medical AG, Zurich) has been developed by a company that also developed an intracranial NIRS probe, which allowed measurements directly in the brain and thus improved algorithms for elimination of the extracranial signals. The investigators aim to determine baseline values and performance of the new device (RheoPatch) compared with a more established NIRS device (NIRO-200NX, Hamamatsu Phototonics, Hamamatsu City, Japan)
Read the detailed description
Primary objective is to compare the RheoPatch NIRS device with the NIRO-200NX NIRS device in volunteers at rest in supine position. As secondary objectives, repeatability of the measurements will be tested with optode reapplications. With measurements in Trendelenburg position, the investigators evaluate the influence of body (head) position on the NIRS signals.
Primary outcome are the baseline values of cerebral oxygenation levels measured by RheoPatch (SbtO2 (%)) and NIRO-200NX (Tissue oxygenation index: TOI (%)).
Secondary endpoints are the repeatability of the measurements with sensor reapplications (coefficient of repeatability, 5 repeats with each device) and changes of the measurements of cerebral oxygenation saturation level in the Trendelenburg position.
Measurements of baseline cerebral oxygenation values are obtained in supine position with 10 measurements, alternating between devices. Combined with 5 min measurement phase for equilibration and power adjustment, this will require 33 minutes per participant.
- Being tested
- Cerebral oximetry using Rheopatch, Cerebral oximetry using NIRO-200NX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oximetry using RheopatchDevice
On the study visit, baseline demographic data (age and gender, BMI) are collected. In supine position the sensor patches (left and right) of the device are applied to the forehead and the cerebral oxymetry values are recorded during 120sec. The sensor patches are then removed and the patches of the second device are applied on the same position on the forehead and the measurement is carried out as described before. For the first measurement of each sensor, a total of 5 minutes equilibration and sensor output power adjustment is allowed. A total of 10 measurements are taken, 5 with each device.
The volunteer is then placed in Trendelenburg position and another 4 measurements are made (2 with each device) as previously described.
Cerebral oximetry using NIRO-200NXDevice
On the study visit, baseline demographic data (age and gender, BMI) are collected. In supine position the sensor patches (left and right) of the device are applied to the forehead and the cerebral oxymetry values are recorded during 120sec. The sensor patches are then removed and the patches of the second device are applied on the same position on the forehead and the measurement is carried out as described before. For the first measurement of each sensor, a total of 5 minutes equilibration and sensor output power adjustment is allowed. A total of 10 measurements are taken, 5 with each device.
The volunteer is then placed in Trendelenburg position and another 4 measurements are made (2 with each device) as previously described.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxygen saturation level
Primary endpoint is the cerebral oxygen saturation level measured by RheoPatch (SbtO2 (%)) and NIRO-200NX (Tissue oxygenation index: TOI (%)). This is the value used for clinical decision making in the daily routine when NIRS measurement devices are used in perioperative medicine or intensive care applications and therefore the most relevant value.
Measured: One day
Secondary outcomes (12)
Changes of the measurements of cerebral oxygenation saturation level (SbtO2 (%) and TOI (%))
SbtO2 and TOI changes are measured
Measured: One day
nTHI_NIRO
Normalized tissue hemoglobin index: nTHI (absolute value in arbitrary unit)
Measured: One day
ΔO2Hb_NIRO
Oxygenated hemoglobin change: ΔO2Hb (μmol/L)
Measured: One day
ΔHHb_NIRO
Deoxygenated hemoglobin change: ΔHHb (μmol/L)
Measured: One day
ΔcHb_NIRO
Total hemoglobin change: ΔcHb (μmol/L)
Measured: One day
aH2O_RP
Absolute concentration of brain tissue water: aH2O (mmol/L)
Measured: One day
aHbDeoxy_RP
Absolute concentration of deoxygenated hemoglobin: aHbDeoxy (μmol/L)
Measured: One day
aHbOxy_RP
Absolute concentration of oxygenated hemoglobin: aHbOxy (μmol/L)
Measured: One day
aHbTotal_RP
Absolute concentration of total hemoglobin: aHbTotal (μmol/L)
Measured: One day
ΔO2Hb_RP
Oxygenated hemoglobin change: ΔO2Hb (μmol/L)
Measured: One day
ΔHHb_RP
Deoxygenated hemoglobin change: ΔHHb (μmol/L)
Measured: One day
ΔcHb_RP
Total hemoglobin change: ΔcHb (μmol/L)
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Jun 2022
- Primary completion1 Mar 2023
- Study completion10 May 2023
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.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabor Erdoes, MD PhD, Study chair, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460585
- Sponsor's protocol ID
- 2021-D0083
- Status last verified
- May 2023
- First submitted
- 5 Jul 2022
- Last updated
- 15 May 2023
- 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 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cerebral Oxygenation Values in Healthy Adults
- ClinicalTrials.gov ID
- NCT05460585
- Acronym / sponsor ID
- 2021-D0083
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 15 Jul 2022 (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.
Noninvasive measurement of cerebral tissue oxygen saturation levels by near infrared spectroscopy (NIRS) is clinical routine in perioperative medicine. One of the main technical challenges of NIRS measurements is to eliminate the influence of signals of the skin and skull. A new device (RheoPatch, Luciole Medical AG, Zurich) has been developed by a company that also developed an intracranial NIRS probe, which allowed measurements directly in the brain and thus improved algorithms for elimination of the extracranial signals. The investigators aim to determine baseline values and performance of the new device (RheoPatch) compared with a more established NIRS device (NIRO-200NX, Hamamatsu Phototonics, Hamamatsu City, Japan)
Detailed description
Primary objective is to compare the RheoPatch NIRS device with the NIRO-200NX NIRS device in volunteers at rest in supine position. As secondary objectives, repeatability of the measurements will be tested with optode reapplications. With measurements in Trendelenburg position, the investigators evaluate the influence of body (head) position on the NIRS signals.
Primary outcome are the baseline values of cerebral oxygenation levels measured by RheoPatch (SbtO2 (%)) and NIRO-200NX (Tissue oxygenation index: TOI (%)).
Secondary endpoints are the repeatability of the measurements with sensor reapplications (coefficient of repeatability, 5 repeats with each device) and changes of the measurements of cerebral oxygenation saturation level in the Trendelenburg position.
Measurements of baseline cerebral oxygenation values are obtained in supine position with 10 measurements, alternating between devices. Combined with 5 min measurement phase for equilibration and power adjustment, this will require 33 minutes per participant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The project population consists of volunteers in subjective good health. Volunteers are chosen to minimize the effect of diseases on the measurements, as the investigators are interested in baseline measurement values and repeatability.
Key inclusion criteria (3 listed)
- Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- Informed Consent signed by the subject
- Subjective good health
Key exclusion criteria (5 listed)
- The presence of any one of the following exclusion criteria will lead to the exclusion of the subject
- Age (<18, > 65 yrs.)
- Forehead skin disease
- Allergy to skin contacting components of NIRS-sensors
- Known cerebrovascular and heart diseases
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 |
|---|---|---|
| Cerebral oximetry using RheopatchOn the study visit, baseline demographic data (age and gender, BMI) are collected. In supine position the sensor patches (left and right) of the device are applied to the forehead and the cerebral oxymetry values are recorded during 120sec. The sensor patches are then removed and the patches of the second device are applied on the same position on the forehead and the measurement is carried out as described before. For the first measurement of each sensor, a total of 5 minutes equilibration and sensor output power adjustment is allowed. A total of 10 measurements are taken, 5 with each device. The volunteer is then placed in Trendelenburg position and another 4 measurements are made (2 with each device) as previously described. | Device | – |
| Cerebral oximetry using NIRO-200NXOn the study visit, baseline demographic data (age and gender, BMI) are collected. In supine position the sensor patches (left and right) of the device are applied to the forehead and the cerebral oxymetry values are recorded during 120sec. The sensor patches are then removed and the patches of the second device are applied on the same position on the forehead and the measurement is carried out as described before. For the first measurement of each sensor, a total of 5 minutes equilibration and sensor output power adjustment is allowed. A total of 10 measurements are taken, 5 with each device. The volunteer is then placed in Trendelenburg position and another 4 measurements are made (2 with each device) as previously described. | Device | – |
Primary outcome
Cerebral oxygen saturation level
Time frame: One day
Primary endpoint is the cerebral oxygen saturation level measured by RheoPatch (SbtO2 (%)) and NIRO-200NX (Tissue oxygenation index: TOI (%)). This is the value used for clinical decision making in the daily routine when NIRS measurement devices are used in perioperative medicine or intensive care applications and therefore the most relevant value.
12 secondary outcomes
Changes of the measurements of cerebral oxygenation saturation level (SbtO2 (%) and TOI (%))
Time frame: One day
nTHI_NIRO
Time frame: One day
ΔO2Hb_NIRO
Time frame: One day
ΔHHb_NIRO
Time frame: One day
ΔcHb_NIRO
Time frame: One day
aH2O_RP
Time frame: One day
aHbDeoxy_RP
Time frame: One day
aHbOxy_RP
Time frame: One day
aHbTotal_RP
Time frame: One day
ΔO2Hb_RP
Time frame: One day
ΔHHb_RP
Time frame: One day
ΔcHb_RP
Time frame: One day
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 15 May 2023.
- 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.
Gabor Erdoes, MD PhD study chair
University of Bern
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 Healthy and Adults, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 5 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 15 May 2023. 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 Switzerland. 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?
Cerebral oxygen saturation level (time frame: One day). 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 15 May 2023.