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

August 15, 2021 updated by: Tobias Werther

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of Pediatrics, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Mechanically Ventilated Preterm Infants

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carbon Dioxide in Mechanically Ventilated Preterm Infants
Time Frame: 48 hours
partial pressure of carbon dioxide
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tobias Werther

Investigators

  • Principal Investigator: Tobias Werther, PhD, Medical University Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

September 26, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

November 26, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 15, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1173/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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