The primary objective of this study is to determine the accuracy of the delta PCO2 (PaCO2-tcPCO2) and delta PO2 (tcPO2 -cPO2) levels for the detection of sepsis. The secondary aims are to determine the factors that influence delta PCO2 and delta PO2…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Decreased and nonspecific blood pressure disorders and shock
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the accuracy determined with the AUC-ROC for the
delta PCO2 (PaCO2 - tcPCO2) and delta PO2 (tcPO2 - cPO2) in patients with and
without sepsis.
Secondary outcome
- To determine the factors influencing delta PCO2 and delta PO2.
- To determine and to determine a trend of delta PCO2 and delta PO2 levels
over time during the onset and treatment of sepsis.
- The influence of ventilation and hemodynamics as measured by ventilation
parameters, patient monitoring parameters and registration of applied
vasopressors on skin perfusion by measuring delta PCO2, delta PO2, delta PI and
delta heating power levels over time.
- Correlation of sensor value deviations and drift from blood gas sample values
between measured tcPCO2, tcPO2, cPCO2, cPO2 and heating power to analyse the
effects of skin temperature and vascularization on measurement accuracy.
- Correlation between delta PCO2, delta PO2 levels and delta heating power and
pulse index (PI) from the pulse oximeter as indicator of impaired perfusion.
- Assessment of the measurement quality and accuracy in patients with
microcirculatory impairment.
- Correlating the delta PCO2, delta PO2, 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 association between the delta PCO2 and blood flow measured
using laser Doppler spectroscopy.
Background summary
Sepsis has a high incidence worldwide and is still one of the major causes of
death at the ICU. Early detection and treatment is crucial in the treatment of
sepsis. 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
hypercarbic and hypoxemic. These deviating carbon dioxide and oxygen 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 and adult
sleep medicine. By locally heating the skin, carbon dioxide and oxygen diffuse
to the skin surface reaching levels that correlate to arterial values. Past
studies that applied a non-heated transcutaneous sensor during sepsis in adults
have shown that non-heated transcutaneous blood gas measurements reflect the
rise in tissue carbon dioxide levels. In addition, a recent study by our
research group on transcutaneous blood gas monitoring in premature neonates
confirmed impairment of the skin oxygen diffusion and consumption during sepsis
or suspected sepsis. A study investigating the ability to detect sepsis in
neonates using abovementioned methods is ongoing in neonates. The applicability
in adults can be investigated using similar methods.
In this study, the condition of the microcirculation will be assessed by
calculating 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 37-38 °C). Additionally, a similar
assessment will be explored by calculating the PO2 difference, or delta PO2,
between transcutaneous measurement of oxygen (tcPO2) and measurement of the
partial arterial oxygen pressure PaO2 based on the oxygen saturation SpO2.
Measurements will be performed with two OxiVenT sensors. The aim of this study
is to evaluate the potential relation of delta PCO2 and delta PO2 to the
microcirculation and thus sepsis.
Study objective
The primary objective of this study is to determine the accuracy of the delta
PCO2 (PaCO2-tcPCO2) and delta PO2 (tcPO2 -cPO2) levels for the detection of
sepsis. The secondary aims are to determine the factors that influence delta
PCO2 and delta PO2 and to determine the trend of delta PCO2 and delta PO2 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 OxiVenT sensors. The sensors for cutaneous
measurements will have a sensor temperature set to 37 to 38°C and will be
blinded for the medical staff. The sensor temperature for transcutaneous
measurements will be set to 41 to 42 °C, according to clinical protocol.
Measurements will be used to evaluate the potential relation of these
parameters to skin perfusion or microcirculation and sepsis. The values will be
compared against blood flow measurements, measured with two laser Doppler
spectroscopy sensors, as a clinical reference for the state of the
microcirculation.
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 to eliminate this risk by
changing the measurement site every 8 hours. 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 sensor will be set to 37- 38 °C 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
Sepsis group:
• Sepsis classified as 2 SIRS criteria and suspected infection
• Signs of hypoperfusion, requiring noradrenaline administration of at least
0.5 µg/min/kg
• Written informed consent.
Control group:
• No fulfillment of 2 SIRS criteria, nor suspected infection
• No signs of hypoperfusion, noradrenaline administration of less than or equal
to 0.5 µg/min/kg
• Written informed consent.
Exclusion criteria
Sepsis group:
• No sepsis
• Skin condition contraindicating transcutaneous blood gas measurements.
• Absence of written informed consent.
Control group:
• Sepsis classified as 2 SIRS criteria and suspected infection
• Skin condition contraindicating transcutaneous blood gas 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 | NL76429.078.22 |