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Capnography Monitoring in Ventilated Children

Accuracy of Capnography Monitoring in Invasively and Non-invasively Ventilated Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04354220
Enrollment
178
Registered
2020-04-21
Start date
2020-06-09
Completion date
2023-12-31
Last updated
2022-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Only, Infant, Newborn, Diseases, Critical Illness, ARDS, Human, Heart Defects, Congenital, Lung Diseases, Obstructive, Lung Diseases, Interstitial

Keywords

capnography, end-tidal CO2, critically ill children, ventilated, accuracy

Brief summary

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.

Interventions

DIAGNOSTIC_TESTcapnography monitoring

routinely used capnography monitoring

DIAGNOSTIC_TESTarterial blood gas

Routinely taken arterial blood gas values

Sponsors

Vincenzo Cannizzaro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 13 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
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 diseaseOn average every participant will be assessed for 5 daysMean 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.

Secondary

MeasureTime frameDescription
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 diseaseOn average every participant will be assessed for 5 daysCardiopulmonary 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026