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

February 4, 2019 updated by: Vera Bernet, MD

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 52 hours
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
Time Frame: 52 hours
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
52 hours
Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin
Time Frame: 52 hours
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
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
52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion
Time Frame: 52 hours
52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types
Time Frame: 52 hours
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
Time Frame: 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
52 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vera Bernet, MD

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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