Trials / Recruiting
RecruitingNCT07478380
Transcutaneous pO₂ Monitoring in PICU
COMPARISON OF TRANSCUTANEOUS PCO₂ AND PO₂ MEASUREMENTS WITH ARTERIAL BLOOD GAS ANALYSIS IN PEDIATRIC INTENSIVE CARE PATIENTS: IS TRANSCUTANEOUS pO₂ A RELIABLE ALTERNATIVE?
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Istanbul Medeniyet University · Academic / Other
- Sex
- All
- Age
- 1 Month – 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
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.
Conditions
Timeline
- Start date
- 2026-03-10
- Primary completion
- 2026-09-01
- Completion
- 2026-10-10
- First posted
- 2026-03-17
- Last updated
- 2026-03-17
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07478380. Inclusion in this directory is not an endorsement.