The primary objective of this pilot study is to determine the technical feasibility of the sensor in clinical practice. Accuracy is investigated with an agreement analysis of transcutaneous measurements and standard of care blood sampling,…
ID
Source
Brief title
Condition
- Other condition
- Body temperature conditions
- Neonatal respiratory disorders
Synonym
Health condition
Prematuriteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the agreement between carbon dioxide values measured
with the new sensor and standard of care blood gas sampling. In addition the
measurement drift is determined.
Secondary outcome
- To evaluate sensor accuracy during hypercapnia and hypocapnia.
- To correlate the transcutaneously measured carbon dioxide levels to the
oxygen levels measured with standard of care cerebral near-infrared
spectroscopy (NIRS) to determine the vascular influence of CO2 levels on
cerebral oxygenation.
- To evaluate the influence of the measured ventilation parameters, patient
monitoring parameters and hemodynamics including the applied vasopressors on
sensor accuracy and functioning
- To evaluate the effects of local skin heating by the new sensor as an
indicator of application safety using the standard application protocols in our
hospital.
- To correlate sensor value deviations and drift from blood gas sample values
between measured tcPCO2 levels to analyze the effects of skin temperature and
vascularization on measurement accuracy.
- To evaluate the effect of patient age and time since birth on measurement
accuracy.
- To assess the measurement quality and accuracy in patients with
microcirculatory impairment.
Background summary
A large portion of the neonates in the neonatal intensive care unit (NICU)
requires respiratory support. For measuring the effects of respiratory support
and adjustment of ventilator settings it is of vital importance to measure
carbon dioxide and oxygen within the body. Commonly the arterial carbon dioxide
pressure is measured through arterial or capillary blood sampling. Neonates
have a small circulating blood volume, limiting the amount of blood that can be
withdrawn. In addition blood sampling is done with large intervals, and
capillary blood sampling causes discomfort. An alternative is the
transcutaneous blood gas measurement of carbon dioxide. By locally heating the
skin carbon dioxide evaporates from the surface, in optimal conditions up to
arterial levels. The current sensors are based on an electrochemical
measurement technique, which suffers from measurement 'drift', requiring
frequent calibration. As a consequence transcutaneously measured carbon dioxide
levels often inadequately represent arterial levels. SenTec AG has recently
developed a new transcutaneous sensor for measuring carbon dioxide, which was
developed with the aim to be free of measurement drift. This is a pilot study
in which the sensor is used for the first time in humans for the assessment of
technical feasibility in the most relevant patient population and most
challenging conditions. The main aim of the study is to evaluate accuracy to
standard of care blood sampling and to determine measurement drift.
Study objective
The primary objective of this pilot study is to determine the technical
feasibility of the sensor in clinical practice. Accuracy is investigated with
an agreement analysis of transcutaneous measurements and standard of care blood
sampling, measurement drift is quantified over time.
Study design
This study is a prospective, blinded observational pilot study. After informed
consent is obtained we will perform continuous transcutaneous measurements of
partial carbon dioxide pressure for 72 hours with the new sensor. The obtained
values are compared to arterial carbon dioxide partial pressure measurements
from standard of care blood gas withdrawals.
Study burden and risks
During 72 hours we will perform non-invasive measurements, of which the burden
is minimal. The sensor is attached with a skin-friendly adhesive which is
regularly used in the NICU. Furthermore, in this study sensor temperature is
set to 41 °C, which is lower than the temperature of currently used
transcutaneous sensors at the NICU (42-43 °C). For sensor site changes we will
adhere to the existing hospital protocol. No additional blood will be drawn,
only results from standard of care blood sampling will be used.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
A gestational age of 24 weeks or older at the time of inclusion.
An arterial catheter.
Written informed consent.
Exclusion criteria
Absence of written informed consent.
Skin condition contraindicating transcutaneous measurements.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL66033.078.18 |