Capnography Monitoring in Ventilated Children

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Diagnostic Test: capnography monitoring
* Diagnostic Test: arterial blood gas


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no shunt, no lung injury<br>ventilated newborns / infants / children with healthy lungs and without or corrected congenital heart disease and no intra-/extra-cardiac shunt | Diagnostic Test: capnography monitoring<br>* routinely used capnography monitoring<br>Diagnostic Test: arterial blood gas<br>* Routinely taken arterial blood gas values<br>|
| mild lung injury<br>ventilated newborns / infants / children with mild lung injury (OI between 4 and 8) | Diagnostic Test: capnography monitoring<br>* routinely used capnography monitoring<br>Diagnostic Test: arterial blood gas<br>* Routinely taken arterial blood gas values<br>|
| moderate-severe lung injury<br>ventilated newborns / infants / children with moderate or severe lung injury (OI above 8) | Diagnostic Test: capnography monitoring<br>* routinely used capnography monitoring<br>Diagnostic Test: arterial blood gas<br>* Routinely taken arterial blood gas values<br>|
| shunt lesion<br>ventilated newborns / infants / children with cyanotic heart diseases and therefore existing intra-cardiac or extra- cardiac right-left shunt lesions | Diagnostic Test: capnography monitoring<br>* routinely used capnography monitoring<br>Diagnostic Test: arterial blood gas<br>* Routinely taken arterial blood gas values<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | On average every participant will be assessed for 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | On average every participant will be assessed for 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capnography, end-tidal CO2, critically ill children, ventilated, accuracy