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Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout
Sponsor: Centre Hospitalier Intercommunal Creteil
Summary
The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses. This objective is of particular interest in the smallest preterm infants, where the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L/minute at the tip of the endotracheal tube to purge expired CO2 trapped in the prostheses, to have a CO2-free volume of gas available for subsequent insufflation. The goal of this clinical trial is to learn if Continuous Tracheal Gas Insufflation (CTGI) works to reduce ventilatory dependence in preterm infants after mechanical ventilation. It will also learn about the safety of CTGI. The main questions it aims to answer are: * Does Continuous Tracheal Gas Insufflation (CTGI) reduce the number of days of non-invasive ventilation in extremely preterm infants who needed mechanical ventilation? * Does Continuous Tracheal Gas Insufflation (CTGI) reduce the age at the weaning of any ventilatory support and/or oxygen supplementation. Researchers will compare the clinical outcome of patients mechanically ventilated with the CTGI-device to the outcome of patients ventilated without the CTGI device, to see if the CTGI ventilation works to reduce ventilation dependence. Participants will: • Be mechanically ventilated using CTGI (if randomly assigned in the CTGI-group), for the entire endotracheal ventilation period during their stay in the neonatal intensive care unit.
Official title: Open Randomised Study of Conventional Ventilation Optimised by Dead Space Washout in Extremely Premature Infants
Key Details
Gender
All
Age Range
Any - 7 Days
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2025-02-13
Completion Date
2029-04-03
Last Updated
2025-02-05
Healthy Volunteers
No
Conditions
Interventions
Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI)
The intervention involves adding a device which allows CTGI (the "CTGI-device") to washout the dead space in preterm mechanically ventilated infants. Dead space washout using the CTGI-device is an option added to standard ventilation, to reduce or even cancel anatomical dead space due to respiratory prostheses in intubated preterm infants.
Locations (4)
Centre Hospitalier Intercommunal de Creteil
Créteil, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Centre Hopistalier Universitaire Cochin Port Royal aphp
Paris, France
Centre hospitalier Robert Debré aphp
Paris, France