Transcutaneous pO₂ Monitoring in PICU

NCT07478380 | Recruiting

• 1 other identifier: CTpCO2MwABGPICP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Critical Illness

Keywords

Pediatric Intensive Care Unit; Transcutaneous Monitoring; Arterial Blood Gas; Noninvasive Monitoring

Outcome Measures

Primary Outcomes (1)

• Agreement Between Transcutaneous pO₂ and Arterial pO₂

  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 Outcomes (1)

• Agreement Between Transcutaneous pCO₂ and Arterial pCO₂

  At the time of each paired transcutaneous monitoring and arterial blood gas measurement during PICU admission (up to 28 days)

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Kadıkoy, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Ayşe Aşık, MD

CONTACT

+905533280449; drayseasik@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Critical Care Fellow, Department of Pediatrics

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 17, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

TU (1)