The primary objective of this study is to determine the relation of delta PO2 (PaO2-tcPO2) and delta PCO2 (tcPCO2-cPCO2) levels to sepsis. The secondary aims are to determine the factors that influence delta PO2 and delta PCO2 and to determine the…
ID
Source
Brief title
Condition
- Other condition
- Body temperature conditions
- Infections - pathogen unspecified
Synonym
Health condition
prematuriteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the relation between delta PO2 (PaO2 - tcPO2) and
delta PCO2 (tcPCO2 - cPCO2) levels and sepsis.
Secondary outcome
Secondary study parameters include:
- Evaluation of the effect of patient age and time since birth on measurement
accuracy.
- The influence of ventilation and hemodynamic as measured by ventilation
parameters, patient monitoring parameters, and registration of applied
vasopressors
on skin perfusion by measuring delta PO2, delta PCO2, delta PI, and delta
heating power levels over time.
- Correlation of sensor value deviations and drift from blood gas sample values
between measured tcPO2, tcPCO2 levels, cPCO2, and heating power to analyze the
effects of skin temperature and vascularization on measurement accuracy.
- Correlation between delta PO2, delta PCO2 levels, and delta heating power and
Pulse Index (PI) from the pulse oximeter as an indicator of impaired perfusion.
- Correlation between delta PO2, delta PCO2 levels, delta PI, and delta heating
power to HeRO-score during impaired microcirculation.
- Assessment of the measurement quality and accuracy in patients with
microcirculatory impairment.
- Correlation of delta PO2, delta PCO2, and delta heating power levels to
changes in NIRS oxygen levels.
- Correlating the delta PO2, delta PCO2, delta PI, and delta heating power to
patient outcome.
- Determine the effect of the sensor location on the level and reliability of
the measurements.
- Determine the relation between sepsis indicated by transcutaneous blood gas
monitoring and questionnaires recording the clinical considerations for blood
culturing by the attending neonatologist.
Background summary
Neonatal sepsis is one of the major causes of death in premature neonates. To
date, there is no consensus on the definition of sepsis. Traditionally, sepsis
is defined as a positive blood culture in which pathogenic bacteria are shown,
combined with clinical decline. Research has shown that the microcirculation
could potentially be an indicator of sepsis, even in an early phase. During
sepsis the microcirculation gets shunted from the arterioles to the venules,
leaving the microcirculation hypoxemic and hypercarbic. These deviating oxygen
and carbon dioxide levels during sepsis could potentially be measured with
transcutaneous blood gas monitoring. Transcutaneous blood gas monitoring has
been available since the 1970s and is used regularly in the premature neonatal
population. By locally heating the skin, carbon dioxide and oxygen diffuse to
the skin surface that correspond to arterial values. A recent study by our
research group on transcutaneous blood gas monitoring in premature neonates
confirms impairment of the skin oxygen diffusion and consumption during sepsis
or suspected sepsis, while carbon dioxide diffusion remains uninfluenced.
In this study, the condition of the microcirculation will be assessed by
calculating the PO2 difference, or delta PO2, between transcutaneous
measurement of oxygen (tcPO2) and measurement of the arterial oxygen
saturation PaO2 based on the SpO2. In addition and the delta PCO2 between
transcutaneous measurement of carbon dioxide (tcPCO2) and cutaneous carbon
dioxide measurement of the skin (cPCO2) with an unheated sensor (sensor
temperature set to 37 °C) will be assessed. Measurements will be performed with
two transcutaneous blood gas sensors and a standard of care pulse oximeter. The
aim of this study is to evaluate the potential relation of delta PO2 and delta
PCO2 to the microcirculation and thus sepsis.
Study objective
The primary objective of this study is to determine the relation of delta PO2
(PaO2-tcPO2) and delta PCO2 (tcPCO2-cPCO2) levels to sepsis. The secondary aims
are to determine the factors that influence delta PO2 and delta PCO2 and to
determine the trend of delta PO2 and delta PCO2 over time.
Study design
This study is a partially blinded prospective observational study. After
informed consent is obtained, continuous transcutaneous measurement of the
partial carbon dioxide and oxygen pressure, and continuous cutaneous
measurement of partial pressures of carbon dioxide will be performed during a
period of two weeks with two transcutaneous blood gas sensors. The sensors for
cutaneous measurements will have a sensor temperature set to 37 °C and will be
blinded for the medical staff. The sensor temperature for transcutaneous
measurements will be set to 42-43 °C, according to clinical protocol.
Measurements will be used to evaluate the potential relation of these
parameters to skin perfusion or microcirculation and sepsis.
Study burden and risks
Transcutaneous carbon dioxide and oxygen sensors locally heats the skin to
several degrees above the body temperature, potentially causing discoloration
of the skin and eventually leading to burns when left in place for too long. As
standard of care, protocols have been implemented in our neonatal and
paediatric intensive care departments to eliminate this risk by regularly
changing the measuring site to prevent burns. In practice, burns have not been
seen in recent years and in particular not at all with this specific sensor.
These standard protocols are adhered to in this study. The temperature of the
unheated transcutaneous blood gas sensor will be set to 37 °C (or core body
temperature of the neonate) so no additional risks or burden are added.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
A gestational age of 24 weeks up to and including 31 weeks at the time of
inclusion.
A pulse oximeter.
Written informed consent
Exclusion criteria
A gestational age of 32 weeks or more at the time of inclusion.
Skin condition contraindicating transcutaneous measurements.
Absence of written informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74106.078.20 |