Capnography Monitoring in Ventilated Children

NCT04354220 | Unknown

• 1 other identifier: KISPI-CAPNO
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

capnography; end-tidal CO2; critically ill children; ventilated; accuracy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

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; Diagnostic Test: arterial blood gas

mild lung injury

ventilated newborns / infants / children with mild lung injury (OI between 4 and 8)

Diagnostic Test: capnography monitoring; Diagnostic Test: arterial blood gas

moderate-severe lung injury

ventilated newborns / infants / children with moderate or severe lung injury (OI above 8)

Diagnostic Test: capnography monitoring; Diagnostic Test: arterial blood gas

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; Diagnostic Test: arterial blood gas

Interventions

capnography monitoring DIAGNOSTIC_TEST

routinely used capnography monitoring

mild lung injury; moderate-severe lung injury; no shunt, no lung injury; shunt lesion

arterial blood gas DIAGNOSTIC_TEST

Routinely taken arterial blood gas values

mild lung injury; moderate-severe lung injury; no shunt, no lung injury; shunt lesion

Eligibility Criteria

• Age: 1 Hour - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vincenzo Cannizzaro: lead

Study Sites (1)

University Children's Hospital

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases; Critical Illness; Respiratory Distress Syndrome; Heart Defects, Congenital; Lung Diseases, Obstructive; Lung Diseases, Interstitial

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior consultant and head of research

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 21, 2020
• Study Start: June 9, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)