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RecruitingNCT07468006Updated Mar 12, 2026

Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children

An observational study in Respiratory Insufficiency in Children, sponsored by Brno University Hospital. Recruiting at 1 site in Czechia. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Brno University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
1 Year to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Insufficiency in Children

Keywords

  • pediatric intensive care
  • transcutaneous capnometry
  • carbon dioxide monitoring
  • blood gas analysis
  • vasopressors
03

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Critically ill pediatric patients admitted to a tertiary PICU with respiratory insufficiency or circulatory compromise.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Partial CO2 difference

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

    Time frame: periprocedural

Secondary outcomes

  1. Proportion of pCO2

    Proportion of tPCO₂ values within ±1 kPa of PaCO₂

    Time frame: periprocedural

  2. Partial O2

    Agreement between transcutaneous oxygen (tPO₂) and PaO₂

    Time frame: periprocedural

  3. Vassopressor use

    Subgroup analysis based on presence of vasopressor support

    Time frame: periprocedural

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT07468006
Lead sponsor
Brno University Hospital
Responsible party
Petr Štourač, MD (prof. Petr Štourač, MD, PhD, MBA, LLM, FESAIC, Brno University Hospital) — Principal investigator
First posted
Mar 12, 2026
Start date
Jan 1, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Jan 31, 2028 (estimated)
Last update
Mar 12, 2026

Study contacts

Hana Harazim, MD, PhD
Contact
hana.harazim@gmail.com
+420777146704

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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