Capnography Monitoring in Ventilated Children

NCT ID: NCT04354220

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-09

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

capnography monitoring

Intervention Type DIAGNOSTIC_TEST

routinely used capnography monitoring

arterial blood gas

Intervention Type DIAGNOSTIC_TEST

Routinely taken arterial blood gas values

mild lung injury

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

capnography monitoring

Intervention Type DIAGNOSTIC_TEST

routinely used capnography monitoring

arterial blood gas

Intervention Type DIAGNOSTIC_TEST

Routinely taken arterial blood gas values

moderate-severe lung injury

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

capnography monitoring

Intervention Type DIAGNOSTIC_TEST

routinely used capnography monitoring

arterial blood gas

Intervention Type DIAGNOSTIC_TEST

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

capnography monitoring

Intervention Type DIAGNOSTIC_TEST

routinely used capnography monitoring

arterial blood gas

Intervention Type DIAGNOSTIC_TEST

Routinely taken arterial blood gas values

Interventions

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capnography monitoring

routinely used capnography monitoring

Intervention Type DIAGNOSTIC_TEST

arterial blood gas

Routinely taken arterial blood gas values

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vincenzo Cannizzaro

OTHER

Sponsor Role lead

Responsible Party

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Vincenzo Cannizzaro

Senior consultant and head of research

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University Children's Hospital

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KISPI-CAPNO

Identifier Type: -

Identifier Source: org_study_id

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