Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07468006

Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Respiratory Insufficiency in Children

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Partial CO2 difference

    Time frame: periprocedural

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

Secondary outcomes

  1. Proportion of pCO2

    Time frame: periprocedural

    Proportion of tPCO₂ values within ±1 kPa of PaCO₂

  2. Partial O2

    Time frame: periprocedural

    Agreement between transcutaneous oxygen (tPO₂) and PaO₂

  3. Vassopressor use

    Time frame: periprocedural

    Subgroup analysis based on presence of vasopressor support

Study contacts

Contact information is provided by the study sponsor or research team.

Hana Harazim, MD, PhD

CONTACT

[email protected]

+420777146704

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.