Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children

March 10, 2026 updated by: Petr Štourač, MD, Brno University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
periprocedural

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

January 31, 2028

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SENTEC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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