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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03060018
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Vera Bernet, MD, University Children's Hospital, Zurich

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.

Condition or disease Intervention/treatment Phase
Critical Illness Device: Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Actual Study Start Date : August 17, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: All included patients
All included patients will undergo the intervention of transcutaneous sensor placement
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.




Primary Outcome Measures :
  1. Bias and precision of the transcutaneous oxygen and carbon dioxide measurements [ Time Frame: 52 hours ]
    Agreement of transcutaneous measurements with capillary and arterial blood gas values at two operational sensor temperatures (42 and 43°C).


Secondary Outcome Measures :
  1. 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 [ Time Frame: 52 hours ]
  2. Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of vasoactive drugs (Adrenalin, Noradrenalin, Dopamine, Dobutamine, Vasopressin, Milrinone) [ Time Frame: 52 hours ]
  3. Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin [ Time Frame: 52 hours ]
  4. 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 [ Time Frame: 52 hours ]
  5. Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements in patients with skin and soft tissue oedema [ Time Frame: 52 hours ]
  6. Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion [ Time Frame: 52 hours ]
  7. Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types [ Time Frame: 52 hours ]
  8. Safety of OxiVenT sensor: Appearance of signs of thermal injury (redness, blisters, necrosis) under application of transcutaneous sensor temperatures of 42 and 43°C [ Time Frame: 52 hours ]
    While operated at sensor temperatures of 42 and 43°C, the skin will be closely observed for any kind of thermic tissue damage



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Ages Eligible for Study:   up to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060018


Locations
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Switzerland
University Children's Hospital Zurich
Zürich, Switzerland, 8032
Sponsors and Collaborators
Vera Bernet, MD
Investigators
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Principal Investigator: Vera Bernet, Prof, MD University of Zurich

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Responsible Party: Vera Bernet, MD, Senior Consultant Pediatric Intensive Care, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier: NCT03060018     History of Changes
Other Study ID Numbers: KISPI-OXIVENT 3.0
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Oxitropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs