Detection of sepsis at the intensive care unit with non-invasive transcutaneous blood gas monitoring.

Detection of sepsis at the intensive care unit with non-invasive transcutaneous blood gas monitoring. - COSMOS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51879

Enrollment

Registered

2022-10-12

Start date

2022-11-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood poisoning sepsis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

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Countries

Netherlands

Outcome results