Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children

NCT07468006 — Recruiting, 20 participants, Brno University Hospital

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Comparison of Transcutaneous Carbon Dioxide Monitoring With Arterialized or Arterial Blood Gas Analysis in PICU

Registry	NCT07468006
Status	Recruiting
Study type	Observational
Enrollment	20 (Estimated)
Sponsor	Brno University Hospital (Other)
Conditions	Respiratory Insufficiency in Children
Dates	start 2026-01-01, primary completion 2027-12-31 (estimated), completion 2028-01-31 (estimated), first posted 2026-03-12, last updated 2026-03-12
Locations	1 site in Czechia

-Summary

Transcutaneous capnometry (tPCO₂) is a non-invasive method for continuous monitoring of ventilation status. In pediatric intensive care patients, it may reduce the need for repeated arterial or arterialized blood sampling. However, the accuracy of tPCO₂ may be influenced by factors such as peripheral perfusion, skin temperature, and vasopressor therapy. This prospective observational study compares transcutaneous carbon dioxide measurements with arterialized or arterial blood gas PaCO₂ values in children with respiratory insufficiency, including a subgroup receiving vasopressor support.

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+Detailed description

This prospective observational study will be conducted in a pediatric intensive care unit to assess agreement between transcutaneous carbon dioxide monitoring and arterialized or arterial blood gas analysis. Consecutive pediatric patients aged 1-18 years with respiratory insufficiency or impaired peripheral perfusion requiring vasopressor support will be included if repeated blood gas sampling is clinically indicated.

Paired measurements of tPCO₂ and PaCO₂ will be analyzed using Bland-Altman methods with correction for repeated measures. Subgroup analyses will evaluate the influence of vasopressor therapy on measurement accuracy. Secondary analyses will compare tPO₂ and PaO₂ values. The study aims to define the clinical applicability and limitations of transcutaneous capnometry in critically ill pediatric patients.

+Outcome measures

Primary outcomes

Partial CO2 difference [periprocedural]: Agreement between transcutaneous CO₂ (tPCO₂) and arterialized or arterial PaCO₂ assessed using Bland-Altman analysis (bias, SD, 95% limits of agreement).

Secondary outcomes

Proportion of pCO2 [periprocedural]: Proportion of tPCO₂ values within ±1 kPa of PaCO₂
Partial O2 [periprocedural]: Agreement between transcutaneous oxygen (tPO₂) and PaO₂
Vassopressor use [periprocedural]: Subgroup analysis based on presence of vasopressor support

+Eligibility

Sex: All, ages: 1 Year to 18 Years

Inclusion Criteria:

* Age 1-18 years
* Diagnosis of respiratory insufficiency or impaired peripheral perfusion
* Expected need for more than one arterialized capillary or arterial blood gas sample
* Admission to PICU

Exclusion Criteria:

* Repeated failure of sensor adhesion
* Hypothermia < 35 °C
* Time difference > ±5 minutes between tPCO₂ and blood sampling
* Large tPCO₂ variability (> ±1 kPa) in 15 minutes preceding blood sampling
* Non-physiological tPCO₂ values incompatible with life

+Locations (1)

Facility	City	Country	Status
University Hospital Brno	Brno	Czechia	Recruiting