Partial blood oxygen and carbon dioxide pressures obtained in critical ill neonates by transcutaneous sensors will be compared to respective values obtained by medically indicated arterial and capillary blood gas analyses. The influence of blood withdrawal method, sensor operational temperature and application time, presence of cyanotic heart malformations and/or intra or extra cardiac right to left shunt, vasoactive drugs, elevated non-conjugated bilirubin, and skin and soft tissue oedema, skin colour and perfusion conditions will be elucidated as well as sensor's safety. Study duration will be 48 hours with sensors applied and additional 4 hours of further surveillance for thermal injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
113
The sensor will be attached to four anatomical positions (thoracic left and right; abdominal left and right), starting with the left thoracic position followed by 4-hourly clockwise position rotation. In case of severe oedema, the ear lobes will be used as anatomical measurement sites and changes to the contralateral ear lobe are made every 4 hours.
University Children's Hospital Zurich
Zurich, Switzerland
Bias and precision of the transcutaneous oxygen and carbon dioxide measurements
Agreement of transcutaneous measurements with capillary and arterial blood gas values at two operational sensor temperatures (42 and 43°C).
Time frame: 52 hours
Agreement of partial transcutaneous oxygen and carbon dioxide pressures with arterial and capillary values in children with echocardiographically determined congenital cyanotic heart disease and/or intra or extra cardiac right to left shunt
Time frame: 52 hours
Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of vasoactive drugs (Adrenalin, Noradrenalin, Dopamine, Dobutamine, Vasopressin, Milrinone)
Time frame: 52 hours
Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin
Time frame: 52 hours
Bias and precision of the oxygen and carbon dioxide transcutaneous measurements over time at one anatomical site with determination of technical drift and physiological drift
Time frame: 52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements in patients with skin and soft tissue oedema
Time frame: 52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion
Time frame: 52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types
Time frame: 52 hours
Safety of OxiVenT sensor: Appearance of signs of thermal injury (redness, blisters, necrosis) under application of transcutaneous sensor temperatures of 42 and 43°C
While operated at sensor temperatures of 42 and 43°C, the skin will be closely observed for any kind of thermic tissue damage
Time frame: 52 hours
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