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

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.

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 Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Device: Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8032
    • University Children's Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: All included patients; All included patients will undergo the intervention of transcutaneous sensor placement

Device: Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor; 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.

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

Collaborators and Investigators

• Sponsor: Vera Bernet, MD
• Investigators: Principal Investigator: Vera Bernet, Prof, MD, University of Zurich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2017
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: February 11, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Physiological Effects of Drugs; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Oxitropium
• Other Study ID Numbers: KISPI-OXIVENT 3.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No