Capnography Monitoring in Ventilated Children

• Conditions: Infant, Newborn, Diseases; Heart Defects, Congenital; Lung Diseases, Interstitial; ARDS, Human; Child, Only; Lung Diseases, Obstructive; Critical Illness
• Interventions: Diagnostic Test: capnography monitoring; Diagnostic Test: arterial blood gas

• Registration Number: NCT04354220
• Lead Sponsor: Vincenzo Cannizzaro

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.

Study Timeline

• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-21
• Study Start: 2020-06-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-18
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mild lung injury	capnography monitoring	ventilated newborns / infants / children with mild lung injury (OI between 4 and 8)
moderate-severe lung injury	capnography monitoring	ventilated newborns / infants / children with moderate or severe lung injury (OI above 8)
shunt lesion	capnography monitoring	ventilated newborns / infants / children with cyanotic heart diseases and therefore existing intra-cardiac or extra- cardiac right-left shunt lesions
mild lung injury	arterial blood gas	ventilated newborns / infants / children with mild lung injury (OI between 4 and 8)
no shunt, no lung injury	arterial blood gas	ventilated newborns / infants / children with healthy lungs and without or corrected congenital heart disease and no intra-/extra-cardiac shunt
no shunt, no lung injury	capnography monitoring	ventilated newborns / infants / children with healthy lungs and without or corrected congenital heart disease and no intra-/extra-cardiac shunt
moderate-severe lung injury	arterial blood gas	ventilated newborns / infants / children with moderate or severe lung injury (OI above 8)
shunt lesion	arterial blood gas	ventilated newborns / infants / children with cyanotic heart diseases and therefore existing intra-cardiac or extra- cardiac right-left shunt lesions

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
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	On average every participant will be assessed for 5 days	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.

Trial Locations

Locations (1)

University Children's Hospital; 🇨🇭 Zurich, Switzerland