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

NCT03060018 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2019-02-05

No results posted yet for this study

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.

Conditions

  • Critical Illness

Interventions

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.

Sponsors & Collaborators

  • Vera Bernet, MD

    lead OTHER

Principal Investigators

  • Vera Bernet, Prof, MD · University of Zurich

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
10 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-17
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03060018 on ClinicalTrials.gov