Transcutaneous Partial Oxygen and Carbon Dioxide Pressures Compared With Blood Gas Values
- Conditions
- Critical Illness
- Interventions
- Device: Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor
- Registration Number
- NCT03060018
- Lead Sponsor
- Vera Bernet, MD
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
- Late premature or term birth newborn infants (34 0/7 until 43 6/7 weeks gestational age (GA)).
- Age between first day of life and 43 6/7 weeks postmenstrual age.
- Ability of care taker to understand verbal and written instructions and informed consent in German.
- Care taker unable or unwilling to give written informed consent in German.
- Care taker not understanding German and without a family member able to translate.
- Written informed consent cannot be obtained for any other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All included patients Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor All included patients will undergo the intervention of transcutaneous sensor placement
- Primary Outcome Measures
Name Time Method Bias and precision of the transcutaneous oxygen and carbon dioxide measurements 52 hours Agreement of transcutaneous measurements with capillary and arterial blood gas values at two operational sensor temperatures (42 and 43°C).
- Secondary Outcome Measures
Name Time Method Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements in patients with skin and soft tissue oedema 52 hours Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin 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 52 hours Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of vasoactive drugs (Adrenalin, Noradrenalin, Dopamine, Dobutamine, Vasopressin, Milrinone) 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 52 hours Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion 52 hours Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types 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 52 hours While operated at sensor temperatures of 42 and 43°C, the skin will be closely observed for any kind of thermic tissue damage
Trial Locations
- Locations (1)
University Children's Hospital Zurich
🇨🇭Zürich, Switzerland