Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT04354220
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
13 Years
Study:
NCT04354220
Study Brief:
Protocol Section:
NCT04354220