Clinical trial NCT04354220: Capnography Monitoring in Ventilated Children
Official title: Accuracy of Capnography Monitoring in Invasively and Non-invasively Ventilated Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 178
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: On average every participant will be assessed for 5 days
Secondary outcomes:
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 with lung and or heart disease
timeFrame: On average every participant will be assessed for 5 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital
Study officials:
References: