Capnography Monitoring in Ventilated Children

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Infant, Newborn, Diseases; Critical Illness; Lung Diseases, Obstructive; Lung Diseases, Interstitial; Heart Defects, Congenital; Child, Only; ARDS, Human
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: Vincenzo Cannizzaro

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: capnography; accuracy; end-tidal CO2; critically ill children; ventilated
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Cardiovascular Abnormalities; Lung Diseases; Lung Diseases, Obstructive; Congenital Abnormalities; Critical Illness; Heart Defects, Congenital; Lung Diseases, Interstitial; Respiratory Distress Syndrome; Infant, Newborn, Diseases
• Other Study ID Numbers: KISPI-CAPNO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No