Respiratory Insufficiency in ChildrenNCT07468006
Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children
An observational study of Respiratory Insufficiency in Children, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Transcutaneous capnometry (tPCO₂) is a non-invasive method for continuous monitoring of ventilation status. In pediatric intensive care patients, it may reduce the need for repeated arterial or arterialized blood sampling. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Respiratory Insufficiency in Children
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2026to 31 Jan 2028
- 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 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Critically ill pediatric patients admitted to a tertiary PICU with respiratory insufficiency or circulatory compromise.
Who may be able to join
- Age 1-18 years
- Diagnosis of respiratory insufficiency or impaired peripheral perfusion
- Expected need for more than one arterialized capillary or arterial blood gas sample
- Admission to PICU
Who cannot join
- Repeated failure of sensor adhesion
- Hypothermia < 35 °C
- Time difference > ±5 minutes between tPCO₂ and blood sampling
- Large tPCO₂ variability (> ±1 kPa) in 15 minutes preceding blood sampling
- Non-physiological tPCO₂ values incompatible with life
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Brno
Brno, 61300
Daniel Diabelko, MD, 727845778 ext. 00420, diabelko.daniel@fnbrno.cz
Hana Harazim, MD, PhD, 777146704 ext. 00420, harazim.hana@fnbrno.cz
About this study
Official title: Comparison of Transcutaneous Carbon Dioxide Monitoring With Arterialized or Arterial Blood Gas Analysis in PICU
Transcutaneous capnometry (tPCO₂) is a non-invasive method for continuous monitoring of ventilation status. In pediatric intensive care patients, it may reduce the need for repeated arterial or arterialized blood sampling. However, the accuracy of tPCO₂ may be influenced by factors such as peripheral perfusion, skin temperature, and vasopressor therapy. This prospective observational study compares transcutaneous carbon dioxide measurements with arterialized or arterial blood gas PaCO₂ values in children with respiratory insufficiency, including a subgroup receiving vasopressor support.
Read the detailed description
This prospective observational study will be conducted in a pediatric intensive care unit to assess agreement between transcutaneous carbon dioxide monitoring and arterialized or arterial blood gas analysis. Consecutive pediatric patients aged 1-18 years with respiratory insufficiency or impaired peripheral perfusion requiring vasopressor support will be included if repeated blood gas sampling is clinically indicated.
Paired measurements of tPCO₂ and PaCO₂ will be analyzed using Bland-Altman methods with correction for repeated measures. Subgroup analyses will evaluate the influence of vasopressor therapy on measurement accuracy. Secondary analyses will compare tPO₂ and PaO₂ values. The study aims to define the clinical applicability and limitations of transcutaneous capnometry in critically ill pediatric patients.
- Conditions
- Respiratory Insufficiency in Children
- Keywords
- pediatric intensive care, transcutaneous capnometry, carbon dioxide monitoring, blood gas analysis, vasopressors
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial CO2 difference
Agreement between transcutaneous CO₂ (tPCO₂) and arterialized or arterial PaCO₂ assessed using Bland-Altman analysis (bias, SD, 95% limits of agreement).
Measured: periprocedural
Secondary outcomes (3)
Proportion of pCO2
Proportion of tPCO₂ values within ±1 kPa of PaCO₂
Measured: periprocedural
Partial O2
Agreement between transcutaneous oxygen (tPO₂) and PaO₂
Measured: periprocedural
Vassopressor use
Subgroup analysis based on presence of vasopressor support
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Insufficiency in ChildrenStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468006
- Sponsor's protocol ID
- SENTEC
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 12 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transcutaneous Carbon Dioxide Monitoring With Arterialized or Arterial Blood Gas Analysis in PICU
- ClinicalTrials.gov ID
- NCT07468006
- Acronym / sponsor ID
- SENTEC
- Conditions
- Respiratory Insufficiency in Children
- Keywords
- pediatric intensive care, transcutaneous capnometry, carbon dioxide monitoring, blood gas analysis, vasopressors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 12 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.
Transcutaneous capnometry (tPCO₂) is a non-invasive method for continuous monitoring of ventilation status. In pediatric intensive care patients, it may reduce the need for repeated arterial or arterialized blood sampling. However, the accuracy of tPCO₂ may be influenced by factors such as peripheral perfusion, skin temperature, and vasopressor therapy. This prospective observational study compares transcutaneous carbon dioxide measurements with arterialized or arterial blood gas PaCO₂ values in children with respiratory insufficiency, including a subgroup receiving vasopressor support.
Detailed description
This prospective observational study will be conducted in a pediatric intensive care unit to assess agreement between transcutaneous carbon dioxide monitoring and arterialized or arterial blood gas analysis. Consecutive pediatric patients aged 1-18 years with respiratory insufficiency or impaired peripheral perfusion requiring vasopressor support will be included if repeated blood gas sampling is clinically indicated.
Paired measurements of tPCO₂ and PaCO₂ will be analyzed using Bland-Altman methods with correction for repeated measures. Subgroup analyses will evaluate the influence of vasopressor therapy on measurement accuracy. Secondary analyses will compare tPO₂ and PaO₂ values. The study aims to define the clinical applicability and limitations of transcutaneous capnometry in critically ill pediatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Critically ill pediatric patients admitted to a tertiary PICU with respiratory insufficiency or circulatory compromise.
Key inclusion criteria (4 listed)
- Age 1-18 years
- Diagnosis of respiratory insufficiency or impaired peripheral perfusion
- Expected need for more than one arterialized capillary or arterial blood gas sample
- Admission to PICU
Key exclusion criteria (5 listed)
- Repeated failure of sensor adhesion
- Hypothermia < 35 °C
- Time difference > ±5 minutes between tPCO₂ and blood sampling
- Large tPCO₂ variability (> ±1 kPa) in 15 minutes preceding blood sampling
- Non-physiological tPCO₂ values incompatible with life
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
Partial CO2 difference
Time frame: periprocedural
Agreement between transcutaneous CO₂ (tPCO₂) and arterialized or arterial PaCO₂ assessed using Bland-Altman analysis (bias, SD, 95% limits of agreement).
3 secondary outcomes
Proportion of pCO2
Time frame: periprocedural
Partial O2
Time frame: periprocedural
Vassopressor use
Time frame: periprocedural
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 12 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 Respiratory Insufficiency in Children, run by Brno University Hospital at 1 site in Czechia.
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 4 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 12 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 Czechia. 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 Hana Harazim, MD, PhD (+420777146704, hana.harazim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial CO2 difference (time frame: periprocedural). 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 12 Mar 2026.