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

NCT ID: NCT05460585

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-05-10

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)

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.

Conditions

Healthy; Adults

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Cerebral oximetry using Rheopatch

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.

Intervention Type: DEVICE

Cerebral oximetry using NIRO-200NX

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Informed Consent signed by the subject
• Subjective good health

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabor Erdoes, MD PhD

Role: STUDY_CHAIR

University of Bern

Locations

Dep. Anesthesiology and Pain Therapy

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

2021-D0083

Identifier Type: -

Identifier Source: org_study_id