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NCT Number: NCT07478380

Transcutaneous pO₂ Monitoring in PICU

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Kadıkoy, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayşe Aşık

CONTACT

[email protected]

05533280449

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

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

Ayşe Aşık, MD

CONTACT

[email protected]

+905533280449

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Mar 17, 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.

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