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

Critical Illness Clinical Trial

— OxiVenT  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060018
• Other study ID #: KISPI-OXIVENT 3.0
• Status: Completed
• Phase: N/A
• Start date: August 17, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Vera Bernet, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bias and precision of the transcutaneous oxygen and carbon dioxide measurements	Agreement of transcutaneous measurements with capillary and arterial blood gas values at two operational sensor temperatures (42 and 43°C).	52 hours
Secondary	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		52 hours
Secondary	Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of vasoactive drugs (Adrenalin, Noradrenalin, Dopamine, Dobutamine, Vasopressin, Milrinone)		52 hours
Secondary	Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin		52 hours
Secondary	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		52 hours
Secondary	Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements in patients with skin and soft tissue oedema		52 hours
Secondary	Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion		52 hours
Secondary	Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types		52 hours
Secondary	Safety of OxiVenT sensor: Appearance of signs of thermal injury (redness, blisters, necrosis) under application of transcutaneous sensor temperatures of 42 and 43°C	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