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

NCT05460585 | Completed

• 1 other identifier: 2021-D0083
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Conditions

Healthy; Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  One day

Secondary Outcomes (12)

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

  One day

• nTHI_NIRO

  One day

• ΔO2Hb_NIRO

  One day

• ΔHHb_NIRO

  One day

• ΔcHb_NIRO

  One day

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Informed Consent signed by the subject
• Subjective good health

You may not qualify if:

• Age (\<18, \> 65 yrs.)
• Forehead skin disease
• Allergy to skin contacting components of NIRS-sensors
• Known cerebrovascular and heart diseases

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. Anesthesiology and Pain Therapy

Bern, 3010, Switzerland

Location

Study Officials

• Gabor Erdoes, MD PhD

  University of Bern

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 15, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 10, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)