Clinical trial NCT03060018: Transcutaneous Partial Oxygen and Carbon Dioxide Pressures Compared With Blood Gas Values
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 113
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Bias and precision of the transcutaneous oxygen and carbon dioxide measurements
timeFrame: 52 hours
Secondary outcomes:
measure: 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
timeFrame: 52 hours
measure: Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of vasoactive drugs (Adrenalin, Noradrenalin, Dopamine, Dobutamine, Vasopressin, Milrinone)
timeFrame: 52 hours
measure: Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin
timeFrame: 52 hours
measure: 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
timeFrame: 52 hours
measure: Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements in patients with skin and soft tissue oedema
timeFrame: 52 hours
measure: Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion
timeFrame: 52 hours
measure: Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types
timeFrame: 52 hours
measure: Safety of OxiVenT sensor: Appearance of signs of thermal injury (redness, blisters, necrosis) under application of transcutaneous sensor temperatures of 42 and 43°C
timeFrame: 52 hours
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Vera Bernet, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baumann P, Gotta V, Adzikah S, Bernet V. Accuracy of a Novel Transcutaneous PCO2 and PO2 Sensor with Optical PO2 Measurement in Neonatal Intensive Care: A Single-Centre Prospective Clinical Trial. Neonatology. 2022;119(2):230-237. doi: 10.1159/000521809. Epub 2022 Feb 4.