Capnography Monitoring in Ventilated Children

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04354220
• Other study ID #: KISPI-CAPNO
• Status: Active, not recruiting
• Start date: June 9, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 178
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• ARDS, Human
• Child, Only
• Congenital Abnormalities
• Critical Illness
• Heart Defects, Congenital
• Infant, Newborn, Diseases
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Respiratory Distress Syndrome

Intervention

Diagnostic Test:
• capnography monitoring
routinely used capnography monitoring
• arterial blood gas
Routinely taken arterial blood gas values

Locations

Country	Name	City	State
Switzerland	University Children's Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Vincenzo Cannizzaro

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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