Transcutaneous pO₂ Monitoring in PICU

March 13, 2026 updated by: Ayse Asik, Istanbul Medeniyet University

COMPARISON OF TRANSCUTANEOUS PCO₂ AND PO₂ MEASUREMENTS WITH ARTERIAL BLOOD GAS ANALYSIS IN PEDIATRIC INTENSIVE CARE PATIENTS: IS TRANSCUTANEOUS pO₂ A RELIABLE ALTERNATIVE?

Arterial blood gas analysis is commonly used in pediatric intensive care units (PICUs) to assess oxygen and carbon dioxide levels in critically ill children. However, arterial blood sampling is invasive, can be painful, and may need to be repeated frequently. Transcutaneous monitoring provides a noninvasive method to continuously measure oxygen (pO₂) and carbon dioxide (pCO₂) levels through the skin, but its accuracy in critically ill pediatric patients requires further evaluation.

The purpose of this observational study is to compare transcutaneous pO₂ and pCO₂ measurements with arterial blood gas values in pediatric intensive care unit patients. By analyzing paired measurements obtained simultaneously during routine clinical care, this study aims to evaluate the agreement between transcutaneous and arterial measurements, with a particular focus on whether transcutaneous pO₂ can serve as a reliable alternative to arterial sampling.

The results of this study may help clarify the role of transcutaneous monitoring in pediatric intensive care and may contribute to reducing the need for invasive blood sampling in selected patients.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Detailed Description

Arterial blood gas (ABG) analysis is the gold standard for assessing oxygenation and ventilation in critically ill children admitted to the pediatric intensive care unit (PICU). Despite its clinical value, ABG sampling is invasive, may cause discomfort, and often requires repeated blood draws. Transcutaneous monitoring offers a noninvasive, continuous method for estimating partial pressures of oxygen (pO₂) and carbon dioxide (pCO₂) through the skin. However, the accuracy and clinical reliability of transcutaneous measurements in critically ill pediatric patients remain variable and require further evaluation.

This observational cohort study aims to assess the agreement between transcutaneous pO₂ (Tc pO₂) and pCO₂ (Tc pCO₂) measurements and corresponding arterial blood gas values (PaO₂ and PaCO₂) in pediatric patients admitted to the PICU. Eligible patients are those who undergo arterial blood gas sampling and concurrent transcutaneous monitoring as part of routine clinical care. Paired measurements will be obtained simultaneously to minimize temporal variability and ensure comparability.

The primary outcome of the study is the agreement between Tc pO₂ and PaO₂ measurements. Secondary analyses will evaluate the agreement between Tc pCO₂ and PaCO₂ values. Agreement will be assessed using appropriate statistical methods, including correlation analysis and Bland-Altman analysis, to determine bias and limits of agreement between measurement techniques.

By evaluating the performance of transcutaneous monitoring in a real-world PICU setting, this study seeks to determine whether Tc pO₂ can be considered a reliable alternative to arterial oxygen measurements in selected pediatric patients. The findings may support the integration of noninvasive monitoring strategies into clinical practice and potentially reduce the frequency of invasive arterial blood sampling in pediatric intensive care.

Study Type

Observational

Enrollment (Estimated)

50

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

  • Turkey (Türkiye)
    • Kadıkoy
      • Istanbul, Kadıkoy, Turkey (Türkiye)
        • Recruiting
        • Göztepe Prof. Dr. Süleyman Yalçın City Hospital
        • Contact:

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

Non-Probability Sample

Study Population

This study will include pediatric patients aged 1 month to 18 years admitted to the Pediatric Intensive Care Unit (PICU) who undergo arterial blood gas analysis and concurrent transcutaneous pCO₂ and pO₂ monitoring as part of routine clinical care. Patients with an indwelling arterial catheter and adequate peripheral perfusion allowing reliable transcutaneous measurements will be eligible. The study population represents critically ill children requiring close respiratory and hemodynamic monitoring in the PICU setting.

Description

Eligibility Criteria

Inclusion Criteria:

  • Age between 1 month and 18 years
  • Admission to the Pediatric Intensive Care Unit (PICU)
  • Presence of an arterial catheter allowing arterial blood gas (ABG) sampling
  • Simultaneous or paired transcutaneous pCO₂ and pO₂ monitoring available
  • Hemodynamically stable at the time of measurement

Exclusion Criteria:

  • Severe skin disease, burns, or local skin infection at the transcutaneous sensor site
  • Severe peripheral perfusion impairment (e.g., refractory shock or high-dose vasopressor support)
  • Congenital or acquired conditions interfering with accurate transcutaneous measurements
  • Technical failure or inability to obtain reliable transcutaneous readings
  • Missing or incomplete paired ABG-transcutaneous measurement data

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
Agreement Between Transcutaneous pO₂ and Arterial pO₂
Time Frame: At the time of each paired transcutaneous monitoring and arterial blood gas measurement during PICU admission (up to 28 days)
Agreement between transcutaneous oxygen partial pressure (Tc pO₂) and arterial oxygen partial pressure (PaO₂) obtained from arterial blood gas analysis in pediatric intensive care unit patients.
At the time of each paired transcutaneous monitoring and arterial blood gas measurement during PICU admission (up to 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement Between Transcutaneous pCO₂ and Arterial pCO₂
Time Frame: At the time of each paired transcutaneous monitoring and arterial blood gas measurement during PICU admission (up to 28 days)
Agreement between transcutaneous carbon dioxide partial pressure (Tc pCO₂) and arterial carbon dioxide partial pressure (PaCO₂) obtained from arterial blood gas analysis in pediatric intensive care unit patients.
At the time of each paired transcutaneous monitoring and arterial blood gas measurement during PICU admission (up to 28 days)

Collaborators and Investigators

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

Sponsor

Istanbul Medeniyet University

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)

March 10, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 10, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTpCO2MwABGPICP

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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