Critical IllnessOxiVenTNCT03060018
Transcutaneous Partial Oxygen and Carbon Dioxide Pressures Compared With Blood Gas Values
A study testing Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor in people with Critical Illness, run by Vera Bernet, MD at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages Up to 10 weeks
- Conditions the study is for
- Critical Illness
- What is being tested?
- Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Aug 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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
- Being tested
- Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| All included patients | Experimental | All included patients will undergo the intervention of transcutaneous sensor placement Receives: Device: Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 52 hours
Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of vasoactive drugs (Adrenalin, Noradrenalin, Dopamine, Dobutamine, Vasopressin, Milrinone)
Measured: 52 hours
Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin
Measured: 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
Measured: 52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements in patients with skin and soft tissue oedema
Measured: 52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion
Measured: 52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types
Measured: 52 hours
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
Measured: 52 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start17 Aug 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vera Bernet, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vera Bernet, MD, University Children's Hospital, Zurich
- Investigators
- Vera Bernet, Prof, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060018
- Sponsor's protocol ID
- KISPI-OXIVENT 3.0
- Acronym
- OxiVenT
- Status last verified
- Feb 2019
- First submitted
- 11 Feb 2017
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35124680
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03060018
- Acronym / sponsor ID
- OxiVenT / KISPI-OXIVENT 3.0
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Vera Bernet, MDUniversity, hospital or other
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All included patients | Experimental | Device: Sentec (SenTec) Digital Monitoring System with OxiVenT SensorAll included patients will undergo the intervention of transcutaneous sensor placement |
Who may qualify
- Ages
- Up to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentec (SenTec) Digital Monitoring System with OxiVenT SensorThe 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. | Device | All included patients |
Primary outcome
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).
8 secondary outcomes
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
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
Bias and precision of oxygen and carbon dioxide transcutaneous measurements under the influence of elevated indirect bilirubin
Time frame: 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
Time frame: 52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements in patients with skin and soft tissue oedema
Time frame: 52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with changing peripheral perfusion
Time frame: 52 hours
Bias and precision of transcutaneous partial oxygen and carbon dioxide pressure measurements with different skin colour types
Time frame: 52 hours
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 35124680Baumann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Bernet, Prof, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor in people with Critical Illness, run by Vera Bernet, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bias and precision of the transcutaneous oxygen and carbon dioxide measurements (time frame: 52 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03060018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019; AzTrials last refreshed its copy on 3 Nov 2026.