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

NCT03758313 | Completed

• 1 other identifier: 1173/2018
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Preterm Infant

Outcome Measures

Primary Outcomes (1)

• Carbon Dioxide in Mechanically Ventilated Preterm Infants

  partial pressure of carbon dioxide

  48 hours

Interventions

CO2 measurements OTHER

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically Ventilated Preterm Infants

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tobias Werther: lead

Study Sites (1)

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

Vienna, 1090, Austria

Location

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MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tobias Werther, PhD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 29, 2018
• Study Start: November 1, 2018
• Primary Completion: September 26, 2020
• Study Completion: September 30, 2020
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

AU (1)