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NOT YET RECRUITING
NCT06334523
NA

Ventilation of the Extremely Premature Infants Optimized by Dead Space Washout

Sponsor: Centre Hospitalier Intercommunal Creteil

View on ClinicalTrials.gov

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

Interventions

DEVICE

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