NCT03060018

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

August 17, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

February 11, 2017

Last Update Submit

February 4, 2019

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of vasoactive drugs (Adrenalin, Noradrenalin, Dopamine, Dobutamine, Vasopressin, Milrinone)

    52 hours

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

    52 hours

  • 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

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

    52 hours

  • +3 more secondary outcomes

Study Arms (1)

All included patients

EXPERIMENTAL

All included patients will undergo the intervention of transcutaneous sensor placement

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

Interventions

Sentec (SenTec) Digital Monitoring System with OxiVenT SensorDEVICE

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.

All included patients

Eligibility Criteria

AgeUp to 10 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Zurich

Zurich, 8032, Switzerland

Location

Related Publications (1)

  • Baumann P, Gotta V, Adzikah S, Bernet V. Accuracy of a Novel Transcutaneous PCO2 and PO2 Sensor with Optical PO2 Measurement in Neonatal Intensive Care: A Single-Centre Prospective Clinical Trial. Neonatology. 2022;119(2):230-237. doi: 10.1159/000521809. Epub 2022 Feb 4.

    PMID: 35124680DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vera Bernet, Prof, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Consultant Pediatric Intensive Care

Study Record Dates

First Submitted

February 11, 2017

First Posted

February 23, 2017

Study Start

August 17, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 5, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)