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Clinical evaluation of a new tcPCO2 sensor in neonates: A pilot study.

Clinical evaluation of a new tcPCO2 sensor in neonates: A pilot study. - NEO-OTC100

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46003
Enrollment
20
Registered
2018-07-09
Start date
2018-07-01
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

Prematuriteit premature birth Prematurity

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: A gestational age of 24 weeks or older at the time of inclusion. An arterial catheter. Written informed consent.

Exclusion criteria

Exclusion criteria: Absence of written informed consent. Skin condition contraindicating transcutaneous measurements.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)