Transcutaneous Partial Oxygen and Carbon Dioxide Pressures Compared With Blood Gas Values

Study Overview
=================
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.

Official Title
-----------------
Agreement of Transcutaneous Partial Oxygen and Carbon Dioxide Pressure With Arterial and Capillary Blood Gas Values. A Single Centre Prospective Non-randomized Trial in Critically Ill Neonates.

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Device: Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Maximum Age: 10 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All included patients<br>All included patients will undergo the intervention of transcutaneous sensor placement | Device: Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 52 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin |  | 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 in patients with skin and soft tissue oedema |  | 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 | While operated at sensor temperatures of 42 and 43°C, the skin will be closely observed for any kind of thermic tissue damage | 52 hours |