Child, OnlyNCT04354220
Capnography Monitoring in Ventilated Children
An observational study of Child, Only and Infant, Newborn, Diseases, run by Vincenzo Cannizzaro at 1 site in Switzerland.
Trial summary
End-tidal CO2 measurements in children will be assessed for their accuracy with arterial CO2 measurements. Read more about this study
- Who is it for?
- Ages 1 hour to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Infant, Newborn, Diseases, Critical Illness
- What is being tested?
- capnography monitoring and arterial blood gas
- How many people
- 178 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jun 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 hour to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Critically ill infants and children under invasive and non-invasive mechanical ventilation, regardless of their underlying acute or chronic diseases, as long as an arterial line for blood gas analyses is in situ.
Who may be able to join
- Children on pressure controlled mechanical invasive or non-invasive ventilation on the Paediatric Intensive Care Unit of the University Children's Hospital Zurich
- Newborns with a birthweight of at least 2.0 kg
- Newborns with an age of at least 1 hour (age > 60 minutes)
- Children up to the last day of the 13th year of living
- Ability of care taker or patient to understand verbal and written instructions and the general consent or informed consent in German or English
- Obtained written general or informed consent as documented by signature
- Available arterial line, i.e. a specific catheter inserted in an artery
Who cannot join
- Care taker or participant unable for linguistic, mental or other reasons or unwilling to understand verbal or written information and to give written informed consent in German or English
- Care taker not available
- Newborns with a birthweight below 2.0 kg
- Newborns younger than 1 hour (age <60 minutes)
- Children with an age of 14 years onwards
- Missing arterial line
Show all 9Show fewer
- Patients dependent on any other kind of respiratory support that is not compatible with the PcCO2-sensor or where a high leakage in the respiratory circuit makes PcCO2 measurements impossible (nasal mask ventilation, low-flow-/high-flow-ventilation, rebreathing mask, high- frequency-oscillation)
- Patients where the investigators act on the assumption that mechanical ventilation will be discontinued and/or the arterial line will be removed within 6 hours or where only one pair of values (arterial and endtidal CO2) can be compared
- Patients with a cyanotic shunt lesion with a weight of 15 kg or above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Capnography Monitoring in Invasively and Non-invasively Ventilated Children
End-tidal CO2 measurements in children will be assessed for their accuracy with arterial CO2 measurements.
Read the detailed description
End-tidal and arterial CO2 measurements will be performed in invasively and non-invasively ventilated critically ill children. The endtidal CO2 values will assessed for their accuracy with respect to different underlying diseases and conditions of the children.
- Conditions
- Child, Only, Infant, Newborn, Diseases, Critical Illness, ARDS, Human, Heart Defects, Congenital, Lung Diseases, Obstructive
- Being tested
- capnography monitoring, arterial blood gas
- Keywords
- capnography, end-tidal CO2, critically ill children, ventilated, accuracy
- Medical subject headings
- Infant, Newborn, Diseases, Critical Illness, Respiratory Distress Syndrome, Heart Defects, Congenital, Lung Diseases, Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capnography monitoringDiagnostic test
routinely used capnography monitoring
arterial blood gasDiagnostic test
Routinely taken arterial blood gas values
| Study group | Role | What they receive |
|---|---|---|
| no shunt, no lung injury | ventilated newborns / infants / children with healthy lungs and without or corrected congenital heart disease and no intra-/extra-cardiac shunt Receives: Diagnostic Test: capnography monitoring; Diagnostic Test: arterial blood gas | |
| mild lung injury | ventilated newborns / infants / children with mild lung injury (OI between 4 and 8) Receives: Diagnostic Test: capnography monitoring; Diagnostic Test: arterial blood gas | |
| moderate-severe lung injury | ventilated newborns / infants / children with moderate or severe lung injury (OI above 8) Receives: Diagnostic Test: capnography monitoring; Diagnostic Test: arterial blood gas | |
| shunt lesion | ventilated newborns / infants / children with cyanotic heart diseases and therefore existing intra-cardiac or extra- cardiac right-left shunt lesions Receives: Diagnostic Test: capnography monitoring; Diagnostic Test: arterial blood gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children without lung or heart disease
Mean absolute measurement difference between simultaneously obtained PaCO2 and PetCO2 values (bias) and their 95% limits of agreement (precision) in children and newborns without cardiopulmonary dysfunction. Units of measure will be in kilopascal (kPa) for PetCO2 and PaCO2, respectively.
Measured: On average every participant will be assessed for 5 days
Secondary outcomes (1)
Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children with lung and or heart disease
Cardiopulmonary function-dependent mean absolute measurement difference between simultaneously obtained PaCO2 and PetCO2 values (bias) and their 95% limits of agreement (precision) in children and newborns with cardiopulmonary dysfunction. Units of measure will be in kilopascal (kPa) for PetCO2 and PaCO2, respectively.
Measured: On average every participant will be assessed for 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start9 Jun 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vincenzo Cannizzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vincenzo Cannizzaro, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354220
- Sponsor's protocol ID
- KISPI-CAPNO
- Status last verified
- May 2022
- First submitted
- 16 Apr 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Capnography Monitoring in Invasively and Non-invasively Ventilated Children
- ClinicalTrials.gov ID
- NCT04354220
- Acronym / sponsor ID
- KISPI-CAPNO
- Conditions
- Child, Only, Infant, Newborn, Diseases, Critical Illness, ARDS, Human, Heart Defects, Congenital, Lung Diseases, Obstructive
- Keywords
- capnography, end-tidal CO2, critically ill children, ventilated, accuracy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Vincenzo CannizzaroUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Apr 2020 (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.
End-tidal CO2 measurements in children will be assessed for their accuracy with arterial CO2 measurements.
Detailed description
End-tidal and arterial CO2 measurements will be performed in invasively and non-invasively ventilated critically ill children. The endtidal CO2 values will assessed for their accuracy with respect to different underlying diseases and conditions of the children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no shunt, no lung injury | – | Diagnostic Test: capnography monitoring, Diagnostic Test: arterial blood gasventilated newborns / infants / children with healthy lungs and without or corrected congenital heart disease and no intra-/extra-cardiac shunt |
| mild lung injury | – | Diagnostic Test: capnography monitoring, Diagnostic Test: arterial blood gasventilated newborns / infants / children with mild lung injury (OI between 4 and 8) |
| moderate-severe lung injury | – | Diagnostic Test: capnography monitoring, Diagnostic Test: arterial blood gasventilated newborns / infants / children with moderate or severe lung injury (OI above 8) |
| shunt lesion | – | Diagnostic Test: capnography monitoring, Diagnostic Test: arterial blood gasventilated newborns / infants / children with cyanotic heart diseases and therefore existing intra-cardiac or extra- cardiac right-left shunt lesions |
Who may qualify
- Ages
- 1 hour to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Critically ill infants and children under invasive and non-invasive mechanical ventilation, regardless of their underlying acute or chronic diseases, as long as an arterial line for blood gas analyses is in situ.
Key inclusion criteria (7 listed)
- Children on pressure controlled mechanical invasive or non-invasive ventilation on the Paediatric Intensive Care Unit of the University Children's Hospital Zurich
- Newborns with a birthweight of at least 2.0 kg
- Newborns with an age of at least 1 hour (age > 60 minutes)
- Children up to the last day of the 13th year of living
- Ability of care taker or patient to understand verbal and written instructions and the general consent or informed consent in German or English
Key exclusion criteria (9 listed)
- Care taker or participant unable for linguistic, mental or other reasons or unwilling to understand verbal or written information and to give written informed consent in German or English
- Care taker not available
- Newborns with a birthweight below 2.0 kg
- Newborns younger than 1 hour (age <60 minutes)
- Children with an age of 14 years onwards
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capnography monitoringroutinely used capnography monitoring | Diagnostic test | mild lung injury, moderate-severe lung injury, no shunt, no lung injury, shunt lesion |
| arterial blood gasRoutinely taken arterial blood gas values | Diagnostic test | mild lung injury, moderate-severe lung injury, no shunt, no lung injury, shunt lesion |
Primary outcome
Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children without lung or heart disease
Time frame: On average every participant will be assessed for 5 days
Mean absolute measurement difference between simultaneously obtained PaCO2 and PetCO2 values (bias) and their 95% limits of agreement (precision) in children and newborns without cardiopulmonary dysfunction. Units of measure will be in kilopascal (kPa) for PetCO2 and PaCO2, respectively.
1 secondary outcome
Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children with lung and or heart disease
Time frame: On average every participant will be assessed for 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Child, Only and Infant, Newborn, Diseases, run by Vincenzo Cannizzaro at 1 site in Switzerland.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 18 May 2022. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of end-tidal Carbon Dioxide (PetCO2) values in comparison to arterial Carbon Dioxide (PaCO2) values in invasively and non-invasively ventilated critically ill children without lung or heart disease (time frame: On average every participant will be assessed for 5 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 18 May 2022.