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

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758313
• Other study ID #: 1173/2018
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Background: 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. Several studies compared etCO2 and tcCO2 to paCO2, simultaneously. A comparison study of etCO2 and tcCO2 in a cohort of critically ill children did not reveal significant differences in the absence of severe pulmonary parenchymal disease. Tobias et al compared etCO2 and tcCO2 in a cohort of pediatric intensive care patients with respiratory failure and found tcCO2 measurements to be more accurate. In a cohort of ventilated newborns, tcCO2 monitoring was generally more precise than etCO2 during neonatal transport to monitor ventilation. In a more recent study restricted to a cohort of postsurgical neonates without lung disease, etCO2 underestimated paCO2 more than tcCO2 but provided greater precision over paCO2, however it was less accurate at smaller tidal volumes. These studies have in common that the adapter of the pCO2 analyzer was attached in-line and proximal to the endotracheal tube. Aim of the study: 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 30, 2020
• Est. primary completion date: September 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Preterm infants with a current body weight between 1000 g and 3000 g who require intubation.
• Signed informed consent from parents or legal guardians.
• Expected to provide at least three measurements of paCO2 and detCO2.

Exclusion Criteria:

• Infants with known congenital anomalies of the heart and/or lung.
• Need for high frequency oscillation.
• Parents or legal guardians deny informed consent.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Other:
• CO2 measurements
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.

Locations

Country	Name	City	State
Austria	Department of Pediatrics, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Tobias Werther

Country where clinical trial is conducted

Austria, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carbon Dioxide in Mechanically Ventilated Preterm Infants	partial pressure of carbon dioxide	48 hours