Comparison of 2 devices for measuring cerebral oxygen saturation in healthy subjects.
Résumé de l'étude
Cerebral oxygen saturation can be measured using light in the near-infrared range. For this, light is emitted and, due to the different reflection of oxygenated and deoxygenated blood, the oxygen content can be estimated. However, a large part of the light is scattered and reflected by the skin and the skull bone, which is why filtering these signals is very important for such devices. A new device should be better at this because the manufacturing company has also measured directly within the brain using this measurement technique and thus possesses very good comparison values. In this study, two different devices are alternately applied to the forehead of healthy subjects to determine and compare the baseline value of cerebral oxygen saturation of these two devices while lying down at rest. These measurements are repeated several times, allowing for a statement about the reliability and repeatability of the measurement to be made. By alternating measurements with the two devices, the subjects themselves serve as a comparison group.
(BASEC)
Intervention étudiée
The subjects are placed in a head-down position after the baseline measurements. This leads to more venous blood being present outside the head, which could distort the measurement. We expect that the new device will be better able to filter this change. Therefore, two additional measurements with both devices are performed in the head-down position.
(BASEC)
Maladie en cours d'investigation
Cerebral oxygen saturation is monitored during various surgeries (for example, on the heart or the aorta as well as on the cerebral vessels). Another area of application is intensive care medicine, for example in patients after resuscitation or after traumatic brain injury.
(BASEC)
Healthy volunteers. (BASEC)
Critères d'exclusion
Age over 65 years, allergies to the components used, known diseases of the cerebral vessels or heart diseases. (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
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Contact pour plus d'informations sur l'étude
Informations scientifiques
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Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
21.04.2022
(BASEC)
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