Pediatric Critical IllnessNCT07478380
Transcutaneous pO₂ Monitoring in PICU
An observational study of Pediatric Critical Illness, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Critical Illness
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 10 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Istanbul, Kadıkoy
Ayşe Aşık, 05533280449, drayseasik@gmail.com
About this study
Official title: 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.
Read the 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
- Pediatric Critical Illness
- Keywords
- Pediatric Intensive Care Unit, Transcutaneous Monitoring, Arterial Blood Gas, Noninvasive Monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At the time of each paired transcutaneous monitoring and arterial blood gas measurement during PICU admission (up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start10 Mar 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Asik, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478380
- Sponsor's protocol ID
- CTpCO2MwABGPICP
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF TRANSCUTANEOUS PCO₂ AND PO₂ MEASUREMENTS WITH ARTERIAL BLOOD GAS ANALYSIS IN PEDIATRIC INTENSIVE CARE PATIENTS: IS TRANSCUTANEOUS pO₂ A RELIABLE ALTERNATIVE?
- ClinicalTrials.gov ID
- NCT07478380
- Acronym / sponsor ID
- CTpCO2MwABGPICP
- Conditions
- Pediatric Critical Illness
- Keywords
- Pediatric Intensive Care Unit, Transcutaneous Monitoring, Arterial Blood Gas, Noninvasive Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Critical Illness, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Aşık, MD (+905533280449, drayseasik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.