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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-17

Study Completion Date

2018-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All included patients

All included patients will undergo the intervention of transcutaneous sensor placement

Group Type EXPERIMENTAL

Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No