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Completed

NCT Number: NCT03060018

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 10 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor

Device

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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

  3. Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin

    Time frame: 52 hours

  4. 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

  5. Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements in patients with skin and soft tissue oedema

    Time frame: 52 hours

  6. Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion

    Time frame: 52 hours

  7. Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types

    Time frame: 52 hours

  8. 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

Sponsors and collaborators

Lead sponsor

Vera Bernet, MD

Other

Registry information

Official study 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.

Acronym: OxiVenT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2017
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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