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Completed

NCT Number: NCT05460585

Cerebral Oxygenation Values in Healthy Adults Volunteers Measured With RheoPatch and NIRO-200NX

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)

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Key information

Conditions

Healthy Adults

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. Anesthesiology and Pain Therapy

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:

  • Informed Consent signed by the subject
  • Subjective good health

Exclusion criteria

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

Treatment and study plan

Cerebral oximetry using Rheopatch

Device

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-200NX

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes of the measurements of cerebral oxygenation saturation level (SbtO2 (%) and TOI (%))

    Time frame: One day

    SbtO2 and TOI changes are measured

  2. nTHI_NIRO

    Time frame: One day

    Normalized tissue hemoglobin index: nTHI (absolute value in arbitrary unit)

  3. ΔO2Hb_NIRO

    Time frame: One day

    Oxygenated hemoglobin change: ΔO2Hb (μmol/L)

  4. ΔHHb_NIRO

    Time frame: One day

    Deoxygenated hemoglobin change: ΔHHb (μmol/L)

  5. ΔcHb_NIRO

    Time frame: One day

    Total hemoglobin change: ΔcHb (μmol/L)

  6. aH2O_RP

    Time frame: One day

    Absolute concentration of brain tissue water: aH2O (mmol/L)

  7. aHbDeoxy_RP

    Time frame: One day

    Absolute concentration of deoxygenated hemoglobin: aHbDeoxy (μmol/L)

  8. aHbOxy_RP

    Time frame: One day

    Absolute concentration of oxygenated hemoglobin: aHbOxy (μmol/L)

  9. aHbTotal_RP

    Time frame: One day

    Absolute concentration of total hemoglobin: aHbTotal (μmol/L)

  10. ΔO2Hb_RP

    Time frame: One day

    Oxygenated hemoglobin change: ΔO2Hb (μmol/L)

  11. ΔHHb_RP

    Time frame: One day

    Deoxygenated hemoglobin change: ΔHHb (μmol/L)

  12. ΔcHb_RP

    Time frame: One day

    Total hemoglobin change: ΔcHb (μmol/L)

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Comparison of Cerebral Oxygenation Values in Healthy Adults

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2022
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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