Capnography Monitoring in Ventilated Children

Sponsor

Vincenzo Cannizzaro (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04354220

Collaborator

(none)

178

Enrollment

Location

42.7

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

End-tidal CO2 measurements in children will be assessed for their accuracy with arterial CO2 measurements.

Condition or Disease	Intervention/Treatment	Phase
Child, Only Infant, Newborn, Diseases Critical Illness ARDS, Human Heart Defects, Congenital Lung Diseases, Obstructive Lung Diseases, Interstitial	Diagnostic Test: capnography monitoring Diagnostic Test: arterial blood gas

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

Study Type:

Observational

Actual Enrollment :

178 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 9, 2020

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Diagnostic Test: capnography monitoring routinely used capnography monitoring Diagnostic Test: arterial blood gas Routinely taken arterial blood gas values
mild lung injury ventilated newborns / infants / children with mild lung injury (OI between 4 and 8)	Diagnostic Test: capnography monitoring routinely used capnography monitoring Diagnostic Test: arterial blood gas Routinely taken arterial blood gas values
moderate-severe lung injury ventilated newborns / infants / children with moderate or severe lung injury (OI above 8)	Diagnostic Test: capnography monitoring routinely used capnography monitoring Diagnostic Test: arterial blood gas Routinely taken arterial blood gas values
shunt lesion ventilated newborns / infants / children with cyanotic heart diseases and therefore existing intra-cardiac or extra- cardiac right-left shunt lesions	Diagnostic Test: capnography monitoring routinely used capnography monitoring Diagnostic Test: arterial blood gas Routinely taken arterial blood gas values

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Hour to 13 Years

Sexes Eligible for Study:

All

Accepts 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