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

V

Vera Bernet, MD

Status

Completed

Conditions

Critical Illness

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03060018
KISPI-OXIVENT 3.0

Details and patient eligibility

About

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.

Enrollment

113 patients

Sex

All

Ages

Under 10 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

113 participants in 1 patient group

All included patients
Experimental group
Description:
All included patients will undergo the intervention of transcutaneous sensor placement
Treatment:
Device: Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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