CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
CO2 measurementsother
Likely dose
Not stated in record
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Search/NCT03758313
NCT03758313N/ACompleted

Non-Invasive Monitoring of Partial Pressure of Carbon Dioxide in Mechanically Ventilated Preterm Infants

Tobias Werther·observational·Posted Nov 29, 2018·Updated Aug 17, 2021

In Brief

An observational study evaluating CO2 measurements for Preterm Infant. Completed, enrolled 27 participants across 1 site.

Detailed Summary

In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an arterial line and, secondly, it does not provide the clinicians with a continuous measurement. At present, two alternative pCO2 monitoring systems are available in the field of neonatal intensive care medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2 (tcCO2) measurements. Both methods have disadvantages including potential technical errors as well as pathologies that may reduce reliability as a surrogate for blood gas analysis (BGA). In particular, conventional side-stream etCO2 capnography underestimates pCO2 in presence of a tube leakage, which is a common occurrence in ventilated preterm infants where only tubes without cuff are used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube may solve the problem of unreliable etCO2 values in the presence of tube leakage. The aim of this study is to compare the agreement, precision and repeatability of the distal etCO2-measurement technique described by Kugelman et al. with respect to paCO2 and tcCO2 in mechanically ventilated preterm infants. Since ventilation strategies and pCO2 limits may vary among different centers, this study helps to determine which non-invasive CO2 monitoring system (detCO2 or tcO2) is more suitable in terms of applicability and reliability in preterm infants at our neonatal intensive care units.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Infant
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 29, 2018
Enrollment StartNov 1, 2018
Primary CompletionSep 26, 2020
Study CompletionSep 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.6 years ago

Interventions

CO2 measurementsother

Distal etCO2, tcCO2 and paCO2 values will be recorded simultaneously in ventilated preterm infants. We will measure etCO2 in a distal position using a double lumen tube connected to an external side-stream capnometer.